Cumulative List of All Orphan Designated and or Approved Products
	Total Number of Active Designations  	1855	Effective:	5/16/2008
	Generic Name	Approved Orphan Indication:
	Trade Name:
	Theralux photodynamic therapy 	Orphan Designation:
	Treatment of chronic graft versus host disease
	Designation 
	4/3/2008	Sponsor and Address
	Marketing Exclusivity 	Kiadis Pharma Canada, Inc.
	2525 Marie Curie
	Montreal (Quebec) H4S 2E1
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trade Name:
	AGT-181	Orphan Designation:
	Treatment of mucopolysaccharidosis Type 1 (MPS)
	Designation 
	1/10/2008	Sponsor and Address
	Marketing Exclusivity 	ArmaGen Technologies, Inc.
	914 Colorado Ave.
	Santa Monica CA  90401 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trade Name:
	Valortim	Orphan Designation:
	Treatment of anthrax infection
	Designation 
	2/16/2006	Sponsor and Address
	Marketing Exclusivity 	PharmAthene, Inc.
	One Park Place
	Suite 450
	Annapolis MD  21401 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(+/- cis-3-(4-hydroxyphenyl)-4-(4-methoxphenyl)-3,4-
	dihydro-2H-chromen-7-01
	Trade Name:
	Orphan Designation:
	Treatment of cholangiocarcinoma
	Designation 
	1/10/2008	Sponsor and Address
	Marketing Exclusivity 	Marshall Edwards, Inc.
	140 Wicks Road

	AUSTRALIA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(+/-)-7-[3-(4-acetyl-3-methoxy-2-
	propylphenoxy)propoxy]-3,4-dihydro-8-propyl-2H-1-
	Trade Name:
	Orphan Designation:
	Prevention of serious adverse events associated with vascular leak syndrome
	 caused by Interleukin-2 therapy
	Designation 
	3/31/2003	Sponsor and Address
	Marketing Exclusivity 	Intarcia Therapeutics, Inc.
	2000 Powell Street 
	Suite 1640
	Emeryville CA  94608 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	(+/-)-cis-3-(4-hydroxyphenyl)-4-(4-methoxyphenyl)-3,4-
	dihydro-2H-chromen-7-0l
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	1/10/2008	Sponsor and Address
	Marketing Exclusivity 	Marshal Edwards, Inc.
	140 Wicks Road

	AUSTRALIA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(+/-)-cis-3-(4-hydroxyphenyl)-4-(4-methoxyphenyl)-3,4-
	dihydro-2Hchromen-7-ol
	Trade Name:
	Orphan Designation:
	Treatment of Stage IIB through Stage IV malignant melanoma
	Designation 
	2/1/2008	Sponsor and Address
	Marketing Exclusivity 	Marshall Edwards, Inc.
	140 Wicks Road

	AUSTRALIA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-
	methoxy-alpha-(1-naphthyl)-beta-phenyl-3-
	quinolineethanol
	Trade Name:
	Orphan Designation:
	Treatment of pulmonary tuberculosis (active disease)
	Designation 
	1/10/2005	Sponsor and Address
	Marketing Exclusivity 	Tibotec, Inc.
	1020 Stony Hill Road
	Yardley PA  19067 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-
	imino-D-ribitol-hydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of chronic lymphocytic leukemia and related leukemias to 
	include prolymphocytic leukemia, adult T-cell leukemia, and hairy cell 
	Designation 	leukemia
	8/10/2004	Sponsor and Address
	Marketing Exclusivity 	BioCryst Pharmaceuticals, Inc.
	2190 Parkway Lake Drive
	Birmingham AL  35244 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-
	imino-D-ribitol-hydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of acute lymphoblastic leukemia
	Designation 
	8/13/2004	Sponsor and Address
	Marketing Exclusivity 	BioCryst Pharmaceuticals, Inc.
	2190 Parkway Lake Drive
	Birmingham AL  35244 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	(1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-
	imino-D-ribitol-hydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of T-cell non-Hodgkin's lymphoma
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	BioCryst Pharmaceuticals, Inc.
	2190 Parkway Lake Drive
	Birmingham AL  35244 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(2Z)-2-cyano-3-3hydroxy-N-[4-(trifluoromethly)phenyl]-
	2-hepten-6-ynamide
	Trade Name:
	FK778	Orphan Designation:
	Prevention of acute rejection following kidney, heart, and liver tranplantation
	Designation 
	1/10/2005	Sponsor and Address
	Marketing Exclusivity 	Fujisawa Healthcare, Inc.
	Three Parkway North
	Deerfield IL  60015-2548
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic
	 acid
	Trade Name:
	Orphan Designation:
	For use in the treatment of cystic fibrosis resulting fron a nonsense 
	(premature stopcodon) mutation in the cystic bibrosis transmembrane 
	Designation 	conductance regulatory gene.
	9/1/2004	Sponsor and Address
	Marketing Exclusivity 	PTC Therapeutics
	100 Corporate Court
	South Plainfield NJ  07080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic
	 acid)
	Trade Name:
	Orphan Designation:
	Treatment of Muscular Dystrophy resulting from premature stop mutations in
	 the dystrohin gene
	Designation 
	1/10/2005	Sponsor and Address
	Marketing Exclusivity 	PTC Therapeutics, Inc.
	100 Corporate Court
	South Plainfield NJ  07080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(3-[5-(2fluorophenyl)-1,2,4-oxadiazol-3-yl]-benzoic 
	acid)
	Trade Name:
	Orphan Designation:
	Treatment of spinal muscular atrophy.
	Designation 
	3/10/2008	Sponsor and Address
	Marketing Exclusivity 	PTC Therapeutics, Inc.
	100 Corporate Court
	South Plainfield NJ  07080 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	(3S)-3-(4-trifluoromethoxybenzyloxy)-6-nitro-2H-3,4-
	dihydroimidazo[2,1-b]oxazine
	Trade Name:
	Orphan Designation:
	Treatment of tuberculosis.
	Designation 
	7/5/2007	Sponsor and Address
	Marketing Exclusivity 	Global Alliance for TB Drug Development
	80 Broad Street
	New York NY  10004 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(3S)-3-[(2S)-2-({N-[2-tert-
	butyl)phenyl]carbamoyl}carbonylamino) 
	propanoylamino]-4-oxo-5-(2,3,5,6-
	Trade Name:
	Orphan Designation:
	Treatment of patients undergoing solid organ transplantation.
	Designation 
	8/19/2003	Sponsor and Address
	Marketing Exclusivity 	Pfizer Global Research and Development
	50 Pequot Avenue
	New London CT  06320 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(4S)-4-ethyl-4-hydroxy-3,14-dioxo-3,4,12,14-
	tetrahydro-1-H-pyrano[3?,4?:6,7]-indolizino-[1,2-b]-
	quinoline-11-carbaldehyde O-(tert-butyl)-(E)-oxime
	Trade Name:
	Gimatecan	Orphan Designation:
	Treatment  malignant glioma
	Designation 
	11/29/2002	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	One Health Plaza
	Building 105
	East Hanover NJ  07936-1080
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(6R,S)5,10-methylene-tetrahydrofolic acid
	Trade Name:
	CoFactor	Orphan Designation:
	For use in combination with 5-fluorouracil for the treatment of patients with 
	pancreatic cancer
	Designation 
	8/13/2004	Sponsor and Address
	Marketing Exclusivity 	Adventrx Pharmaceuticals, Inc.
	6725 Mesa Ridge Road
	Suite 100
	San Diego CA  92121 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(9-[N-(3-morpholinopropyl)-sulfonyl]-5,6-dihydro-5-
	oxo-11-H-indeno [1,2-c] isoquinoline 
	Trade Name:
	Orphan Designation:
	Prevention of post-operative complications of aortic anuerysm surgical repair
	Designation 
	12/8/2004	Sponsor and Address
	Marketing Exclusivity 	Inotek Pharmaceuticals Corporation
	100 Cummings Center
	Beverly MA  01915 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	(R)-2-methyl-6-nitro-2-{4-[4-(4-
	trifluoromethoxyphenoxy)piperidin-1-
	yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole
	Trade Name:
	Orphan Designation:
	Treatment of pulmonary tuberculosis.
	Designation 
	7/12/2007	Sponsor and Address
	Marketing Exclusivity 	Otsuka Pharmaceutical Company, Ltd
	2440 Research Blvd
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(R)-4-(3-morpholin-4-yl-1-phenylsulfanylmethyl-
	propylamino)-N-(4-{4-[2-(4-chlorophenyl)-5,5-
	dimethylcyclohex-1-enylmethyl]-piperazin-1-yl}-
	benzoyl)-3-
	trifluoromethanesulfonylbenzenesulfonamide bis-
	Trade Name:
	Orphan Designation:
	Treatment of small cell lung cancer
	Designation 
	12/19/2007	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	200 Abbott Park Road
	AP34/RA72
	Abbott Park IL  60064-6188
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(R)-4-(3-morpholin-4-yl-1-phenylsulfanylmethyl-
	propylamino)-N-(4-{4-[2-(4-chlorophenyl)-5,5-
	dimethylcyclohex-1-enylmethyl]-piperazin-1-yl}-
	benzoyl)-3-
	trifluoromethanesulfonylbenzenesulfonamide bis-
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	5/5/2008	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	200 Abbott Park Road
	Abbott Park IL  60064 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(R)-4-(3-morpholin-4-yl-l-phenylsulfanylmenthyl-
	propylamino)-N-(4-{4-[2-(4-chlorophenyl)-5,5-
	dimethylcyclohex-l-enylmethyl]-piperazin-l-yl}-
	benzoyl)-3-
	trifluoromethanesulfonylbenzenesulfonamide bis-
	Trade Name:
	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	12/19/2007	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	200 Abbaott Park Road
	AP34/RA72
	Abbott Park IL  60064-6188
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(R)-N-[2-(6-chloro-5-methoxy-1H-indol-3-
	yl)propyl]acetamide
	Trade Name:
	Orphan Designation:
	Treatment of circadian rhythm sleep disorders in blind people with no light 
	perception
	Designation 
	10/3/2001	Sponsor and Address
	Marketing Exclusivity 	Phase 2 Discovery, Inc.
	3130 Highland Avenue, Third Floor
	Cincinnati OH  45219-2374
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	(R)-N-[2-(6-Chloro-methoxy-1H-indol-
	3yl)propyl]acetamide
	Trade Name:
	Orphan Designation:
	Treatment of neuroleptic-induced tardive dyskinesia in schizophrenia 
	patients
	Designation 
	7/3/2003	Sponsor and Address
	Marketing Exclusivity 	Phase 2 Discovery, Inc.
	3130 Highland Ave.
	Third Floor
	Cincinnati OH  45219 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	(UDU-stereoisomer of c-UJUun UNU-terminal 
	UkUnhibitor)
	Trade Name:
	Orphan Designation:
	Treatment of acute sensorineural hearing loss
	Designation 
	3/28/2006	Sponsor and Address
	Marketing Exclusivity 	Auris Medical, Inc.
	211 East Ontario Street
	Chicago IL  60611 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	[5,10,15,20-tetrakis(1,3-diethylimidazolium-2-
	yl)porphyrinato] manganese(III)pentachloride
	Trade Name:
	Orphan Designation:
	Treatment of Amyotrophic Lateral Sclerosis
	Designation 
	11/4/2003	Sponsor and Address
	Marketing Exclusivity 	Aeolus Pharmaceuticals, Inc.
	PO Box 14287; 79 T.W. Alexander Dr. 
	4401 Research
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	1,1'-[1,4-phenylenebis(methylene)-bis-1,4,8,11-
	tetraazacyclotetradecan
	Trade Name:
	Orphan Designation:
	For use to improve the yield of progentor cells in the apheresis product for 
	subsequest stem cell transplantation following myelosuppressive or 
	Designation 	myeloablative chemotherapy
	7/10/2003	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	500 Kendall Street
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	1,2-bis(methylsulfonyl)-1-(2-chloroethyl)-2-
	[(methylamino)carbonyl]hydrazine
	Trade Name:
	Cloretazine	Orphan Designation:
	Treatment of acute myelogenous leukemia 
	Designation 
	10/21/2004	Sponsor and Address
	Marketing Exclusivity 	Vion Pharmaceuticals, Inc.
	Four Science Park
	New Haven CT  06511 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	1,5-(Butylimino)-1,5 dideoxy,D-glucitol
	Trade Name:
	Orphan Designation:
	Treatment of Fabry's disease.
	Designation 
	5/12/1998	Sponsor and Address
	Marketing Exclusivity 	Oxford GlycoSciences
	10, The Quadrant
	Abington Science Park
	United Kingdom    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	11-(2-Pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-
	triaza-tetracyclo[19.3.1.12,6.18,12}heptacosa-
	1(25),2(26),3,5,8,10,12(27),16,21,23-decaene
	Trade Name:
	Orphan Designation:
	For treatment of myeloproliferative disorders (MPD) with the JAK2 V617F 
	mutation.
	Designation 
	3/13/2008	Sponsor and Address
	Marketing Exclusivity 	S*BIO Pte., Ltd.
	1 Science Park Road
	Singapore Science Park II
	    
	SINGAPORE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	111Indium pentetreotide
	Trade Name:
	SomatoTher	Orphan Designation:
	Treatment of somatostatin receptor positive neuroendocrine tumors.
	Designation 
	6/10/1999	Sponsor and Address
	Marketing Exclusivity 	Louisiana State University Medical Center Foundation
	1600 Canal St.
	10th Floor
	New Orleans LA  70112 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	166Ho-DOTMP
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma.
	Designation 
	2/10/1999	Sponsor and Address
	Marketing Exclusivity 	NeoRx Corporation
	410 W. Harrison Street
	Seattle WA  98119-4007
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	17 a-Hydroxyprogesterone caproate
	Trade Name:
	Gestiva	Orphan Designation:
	Prevention of preterm birth in singleton pregnancies
	Designation 
	1/25/2007	Sponsor and Address
	Marketing Exclusivity 	Cytyc Corporation
	1240 Elko Drive
	Sunnyvale CA  94089 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	17-allylamino-17-demethoxygeldanamycin (17-AGG)
	Trade Name:
	Orphan Designation:
	For the treatment of chronic myelogenous leukemia
	Designation 
	9/3/2004	Sponsor and Address
	Marketing Exclusivity 	Kosan Biosciences, Inc.
	3832 Bay Center Place
	Hayward CA  94545 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	1-Deoxygalactonojirimycin
	Trade Name:
	Orphan Designation:
	Treatment of Fabry Disease
	Designation 
	2/25/2004	Sponsor and Address
	Marketing Exclusivity 	Amicus Therapeutics, Inc.
	6 Cedar Brook Drive
	Cranbury NJ  08512 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	1-dexynojirimycin hydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of Pompe disease
	Designation 
	6/18/2007	Sponsor and Address
	Marketing Exclusivity 	Amicus Therapeutics, Inc
	6 Cedar Brook Drive
	Cranbury NJ  08512 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylic 
	acid
	Trade Name:
	Orphan Designation:
	Treatment of familial amyloid polyneuropathy
	Designation 
	5/23/2006	Sponsor and Address
	Marketing Exclusivity 	FoldRx Pharmaceuticals, Inc.
	300 Technology Square
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2-(3-diethylaminopropyl)-8,8-dipropyl-2-azaspiro [4,5]
	 decan dimaleate
	Trade Name:
	Atiprimod	Orphan Designation:
	Treatment of mulitple myeloma and associated bone resorption
	Designation 
	12/2/2003	Sponsor and Address
	Marketing Exclusivity 	Callisto Pharmaceuticals, Inc.
	2 Executive Drive
	Suite 450
	Somerset NJ  08873 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	2-(3-Diethylaminopropyl)-8,8-dipropyl-2-azaspiro[4,5] 
	decane dimaleate
	Trade Name:
	Atiprimod	Orphan Designation:
	Treatment of carcinoid tumors
	Designation 
	9/18/2006	Sponsor and Address
	Marketing Exclusivity 	Callisto Pharmaceuticals, Inc.
	420 Lexington Avenue
	New York NY  10170 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2',3',5'-tri-o-acetyluridine
	Trade Name:
	Orphan Designation:
	Treatment of mitochondrial disease
	Designation 
	1/13/2003	Sponsor and Address
	Marketing Exclusivity 	Repligen Corporation
	41 Seyon Street
	Building 1, Suite 100
	Waltham MA  02453 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2,6-Benzothiazolediamine, 4,5,6,7-tetrahydro-N6-
	propyl-, dihydrochloride, monohydrate, (6R)-; (6R)-
	4,5,6,7-tetrahydro-N6-propyl-2,6-
	benzothiazolediamine dihydrochloride monohydrate
	Trade Name:
	Orphan Designation:
	Treatment of amyothrophic lateral sclerosis (ALS).
	Designation 
	10/11/2007	Sponsor and Address
	Marketing Exclusivity 	Knopp Neurosciences, Inc.
	2100 Wharton Street
	Pittsburgh PA  15203 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2-[(R)-2-methylpyrrolidin-2-yl]-1H-benzimadazole-4-
	carboxamide
	Trade Name:
	Orphan Designation:
	Treatment of malignant melanoma stages IIb through IV.
	Designation 
	12/18/2007	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	Global Pharmaceutical Research and Development
	200 Abbott Park Road
	Abbott Park IL  60064-6157
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2-[(R)-2-methylpyrrolidin-2-yl]-1H-benzimadazole-4-
	carboxamide
	Trade Name:
	Orphan Designation:
	Treatment glioblastoma multiforme when used in combination with DNA-
	damaging agents
	Designation 
	5/9/2008	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	Global Pharmaceutical Research and Development
	Abbott Park IL  60064 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	2-0-Butyryl-1-0-octyl-myo-inositol 3,4,5,6-
	tetrakisphosphate
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	8/15/2003	Sponsor and Address
	Marketing Exclusivity 	Inologic, Inc.
	101 Elliott Ave., West
	Seattle WA  98119 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2-0-desulfated heparin
	Trade Name:
	Aeropin	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	9/17/1993	Sponsor and Address
	Marketing Exclusivity 	Kennedy & Hoidal, M.D.'s
	University of Utah Health Sciences Center
	50 North Medical Drive, Room 4R240
	Salt Lake City UT  84132 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	20-mer complementary to Akt mRNA
	Trade Name:
	Orphan Designation:
	Treatment of stomach cancer
	Designation 
	12/10/2004	Sponsor and Address
	Marketing Exclusivity 	Rexahn Corporation
	9620 Medical center Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	20-mer oligonucleotide complementary to Akt mRNA
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	12/8/2004	Sponsor and Address
	Marketing Exclusivity 	Rexahn Corporation
	9620 Medical Center Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	20-mer oligonucleotide complementary to Akt mRNA
	Trade Name:
	Orphan Designation:
	Treatment of glioblastoma
	Designation 
	12/8/2004	Sponsor and Address
	Marketing Exclusivity 	Rexahn Corporation
	9620 Medical center Drive
	Rockville MD  20850 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	20-mer oligonucleotide complementary to Akt mRNA
	Trade Name:
	Orphan Designation:
	Treatment of renal cell carcinoma
	Designation 
	12/1/2004	Sponsor and Address
	Marketing Exclusivity 	Rexahn Corporation
	9620 Medical Center Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	20-mer oligonucleotide complementary to Akt mRNA
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer
	Designation 
	12/1/2004	Sponsor and Address
	Marketing Exclusivity 	Rexahn Corporation
	9620 Medical Center Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2'-3'-dideoxyadenosine
	Trade Name:
	Orphan Designation:
	Treatment of aquired immunodeficiency syndrome.
	Designation 
	7/21/1987	Sponsor and Address
	Marketing Exclusivity 	National Cancer Institute, Dct
	NIH, Exec. Plaza N., Room 7-18
	Bethesda MD  20892 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	24,25 dihydroxycholecalciferol
	Trade Name:
	Orphan Designation:
	Treatment of uremic osteodystrophy.
	Designation 
	2/27/1987	Sponsor and Address
	Marketing Exclusivity 	Lemmon Company
	1510 Delp Drive
	Kulpsville PA  19443 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2-chloroethyl-3-sarcosinamide-1-nitrosourea
	Trade Name:
	Orphan Designation:
	Treatment for malignant gliomas
	Designation 
	8/3/2001	Sponsor and Address
	Marketing Exclusivity 	Lawrence Panasci, MD
	Professor of Medicine, McGill University
	3755 Cote Ste Catherine
	Montreal, Quebec H3T 1E2    
	CANADA
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	2-chloroethyl-3-sarcosinamide-1-nitrosourea
	Trade Name:
	Sarmustine	Orphan Designation:
	Treatment for malignant glioma
	Designation 
	11/15/2001	Sponsor and Address
	Marketing Exclusivity 	Pangene Corporation
	5500 Stewart Avenue
	Fremont CA  94538 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2'-deoxycytidine
	Trade Name:
	Orphan Designation:
	As a host-protective agent in the treatment of acute myelogenous leukemia.
	Designation 
	9/9/1996	Sponsor and Address
	Marketing Exclusivity 	Grant, Steven M.D.
	Massey Cancer Center, VCU
	P.O. Box 980230
	Richmond VA  23298-0230
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2-methoxyestradiol
	Trade Name:
	PulmoLAR	Orphan Designation:
	Treatment of pulmonary arterial hypertension
	Designation 
	4/11/2005	Sponsor and Address
	Marketing Exclusivity 	PR Pharmaceuticals, Inc.
	1716 Heath Parkway
	Fort Collins CO  80524 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2-methoxyestradiol
	Trade Name:
	Panzem NCD	Orphan Designation:
	Treatment of ovarian cancer
	Designation 
	4/4/2005	Sponsor and Address
	Marketing Exclusivity 	EntreMed, Inc.
	9640 Medical Center Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2-methoxyestradiol
	Trade Name:
	Panzem	Orphan Designation:
	Treatment of multiforme glioblastoma
	Designation 
	6/16/2006	Sponsor and Address
	Marketing Exclusivity 	EntreMed, Inc.
	9640 Medical Center Drive
	Rockville MD  20850 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	2-methoxyestradiol
	Trade Name:
	Panzem	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	7/10/2001	Sponsor and Address
	Marketing Exclusivity 	EntreMed, Inc.
	9640 Medical Center Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	2'-O-methyl-phosphorothiolate oliogribonucleotide
	Trade Name:
	Orphan Designation:
	Treatment of Duchenne muscular dystrophy 
	Designation 
	11/18/2005	Sponsor and Address
	Marketing Exclusivity 	Prosena B.V.
	Einsteinweg 55

	NETHERLANDS
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	3-(3,5-Dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-
	2-one
	Trade Name:
	Orphan Designation:
	Treatment of von Hippel-Lindau disease.
	Designation 
	3/23/2000	Sponsor and Address
	Marketing Exclusivity 	Sugen, Inc.
	230 East Grand Ave.
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	3-(3,5-dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-
	2-one
	Trade Name:
	Orphan Designation:
	Treatment of Kaposi's sarcoma.  
	Designation 
	9/11/1998	Sponsor and Address
	Marketing Exclusivity 	Sugen, Inc.
	230 East Grand Ave.
	South San Francisco CA  94080-4811
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	3,4-diaminopyridine
	Trade Name:
	Orphan Designation:
	Treatment of Lambert-Eaton myasthenic syndrome.  
	Designation 
	12/18/1990	Sponsor and Address
	Marketing Exclusivity 	Jacobus Pharmaceutical Company
	37 Cleveland Avenue
	P.O. Box 5290
	Princeton NJ  08540 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	3,5,3'-triiodothyroacetate
	Trade Name:
	Orphan Designation:
	Treatment of well-differentiated papillary, follicular or combined 
	papillary/follicular carcinomas of the thyroid gland.
	Designation 
	9/20/2000	Sponsor and Address
	Marketing Exclusivity 	Elliot Danforth, Jr., M.D.
	University of Vermont
	84 Beartown Road
	Underhill VT  05489 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	3'-azido-2',3'dideoxyuridine
	Trade Name:
	AZDU	Orphan Designation:
	Treatment of acquired immunodeficiency syndrome.
	Designation 
	11/20/1989	Sponsor and Address
	Marketing Exclusivity 	Berlex Laboratories, Inc.
	1401 Harbor Bay Parkway
	Alameda CA  94501 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	4-(2-fluorophenyl)-6-methyl-2-(1-piperzinyl) 
	Trade Name:
	Orphan Designation:
	Treatment of Chronic Functional Vomiting to include functional vomiting 
	and cyclic vomiting syndrome.
	Designation 
	10/11/2006	Sponsor and Address
	Marketing Exclusivity 	Dynogen Pharmaceuticals, Inc.
	52 Second Avenue
	Waltham MA  02451 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	4-(3-Methanesulfonyl-phenyl)-1-propylpiperidine HCl
	Trade Name:
	Orphan Designation:
	Treatment of Huntington disease.
	Designation 
	12/12/2005	Sponsor and Address
	Marketing Exclusivity 	A. Carlsson Research AB
	Joakim Tedroff, M.D.
	S-412 46 Goteborg
	    
	SWEDEN
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	4,5 dibromorhodamine methyl ester
	Trade Name:
	Theralux Photodynamic Therapy 	Orphan Designation:
	For immune reconstitution and prevention of graft versus host disease 
	following allogeneic hematopoietic stem cell transplantation.
	Designation 
	10/23/2007	Sponsor and Address
	Marketing Exclusivity 	Kiadis Pharma Canada, Inc.
	2525 Marie Curie
	Canada H4S 2E1
	    
	CANADA
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	4,5-dibromorhodamine 123
	Trade Name:
	Theralux Irradiation Device	Orphan Designation:
	Treatment of chronic myelogenous leukemia
	Designation 
	4/10/2003	Sponsor and Address
	Marketing Exclusivity 	Kiadis Pharma Canada, Inc.
	2525 Marie-Curie
	Saint-Laurent (Quebec) H4S 2E1
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	40SD02
	Trade Name:
	Orphan Designation:
	Treatment of chronic iron overload resulting from conventional 
	transfusional treatment of beta-thalassemia major and sickle cell anemia.
	Designation 
	12/21/1998	Sponsor and Address
	Marketing Exclusivity 	Biomedical Frontiers, Inc.
	1095 10th Ave., S.E.
	Minneapolis MN  55414 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	4-Amino-1-[5-O-[(2R, 4S)-2-oxido-4-(4-pyridinyl)-1, 3, 
	2-dioxaphosphorinan-2-yl]-b-D-arabinofuranosyl]-
	2(1H)-pyrimidinone
	Trade Name:
	Orphan Designation:
	Treatment of hepatocellular carcinoma.
	Designation 
	8/22/2007	Sponsor and Address
	Marketing Exclusivity 	Metabasis Therapeutics, Incorporated
	11119 North Torrey Pines Road
	LaJolla CA  92037 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	4-Aminopyridine
	Trade Name:
	Orphan Designation:
	Treatment chronic functional motor and sensory deficits from Guillain-Barre
	 syndrome
	Designation 
	12/14/2005	Sponsor and Address
	Marketing Exclusivity 	Acorda Therapeutics, Inc.
	15 Skyline Drive
	Hawthorne NY  10532 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	4-aminosalicylic acid 
	Trade Name:
	Paser Granules	Orphan Designation:
	Treatment of acute flares in pediatric patients with ileo-cecal Crohn's disease
	Designation 
	4/26/2006	Sponsor and Address
	Marketing Exclusivity 	Jacobus Pharmaceutical Co., Inc.
	37 Cleveland Lane
	Princeton NJ  08540 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	4-aminosalicylic acid
	Trade Name:
	Pamisyl (P-D), Rezipas (Squibb)	Orphan Designation:
	Treatment of mild to moderate ulcerative colitis in patients intolerant to 
	sulfasalazine.
	Designation 
	12/13/1989	Sponsor and Address
	Marketing Exclusivity 	Beeken, Warren M.D.
	University Of Vermont
	Given C-317
	Burlington VT  05405 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	4-cholest-en-3-one, oxime
	Trade Name:
	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis 
	Designation 
	12/1/2005	Sponsor and Address
	Marketing Exclusivity 	Trophos SA
	Parc scientifique de Lumigny, Case 931
	1322 Marseille cedex
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	4-cyano-N-[2-(1-cyclohexen-1-yl)-4-[1-
	[dimethylamino)acetyl]-4-piperidinyl]phenyl]-1H-
	imidazole-2-carboxamide monohydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of acute myeloid leukemia
	Designation 
	7/20/2006	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical Research & Dev, 
	920 U S Highway 202
	P.O. Box 300
	Raritan NJ  08869 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	4-trifluoromethyl-N-(3.3a.4.4a.5,5a,6,6a-octahydro-
	1,3-dioxo-4,6ethenocycloprop[f]isoindol-2(1H)-yl)-
	Trade Name:
	Orphan Designation:
	Treatment of smallpox.
	Designation 
	12/27/2006	Sponsor and Address
	Marketing Exclusivity 	SIGA Technologies, Inc.
	4575 SW Research Way
	Corvallis OR  97333 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	4-trifluoromethyl-N-(3.3a.4.4a.5,5a,6,6a-octahydro-
	1,3-dioxo-4,6ethenocycloprop[f]isoindol-2(1H)-yl)-
	Trade Name:
	Orphan Designation:
	post exposure prophylaxis against smallpox
	Designation 
	12/18/2006	Sponsor and Address
	Marketing Exclusivity 	SIGA Technologies, Inc.
	4575 SW Research Way
	Corvallis OR  97333 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	5(S)-(2'-hydroxy ethoxy)-20(S)-Camptothecin
	Trade Name:
	Orphan Designation:
	Treatment of osteosarcoma (bone cancer)
	Designation 
	6/15/2007	Sponsor and Address
	Marketing Exclusivity 	ClinTec International Ltd.
	1055 Westlakes Drive
	Berwyn PA  19312 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	5,12-Naphthacenedione, 10-[[3-amino-2,3,6-trideoxy-
	4-O-(phenylmethyl)-a-L-lyxo-hexopyranosyl]oxy]-
	7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-
	(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S,10S)- 
	Trade Name:
	Orphan Designation:
	Treatment of malignant gliomas
	Designation 
	10/11/2006	Sponsor and Address
	Marketing Exclusivity 	Reata Pharmaceuticals, Inc.
	1950 N. Stemmons Freeway
	Dallas TX  75207-3199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	5,5',5"-[Phosphinothioylidyne-tris(imino-2,1-
	ethanediyl)]tris[5-methylchelidoninium]trihydroide 
	hexahydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	8/20/2003	Sponsor and Address
	Marketing Exclusivity 	Now Pharm AG
	241, route d'Arlon
	L-1150
	    
	LUXEMBOURG
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	5,6-dihydro-5-azacytidine
	Trade Name:
	Orphan Designation:
	Treatment of malignant mesothelioma.
	Designation 
	5/11/1992	Sponsor and Address
	Marketing Exclusivity 	ILEX Oncology, Inc.
	4545 Horizon Hill Blvd.
	San Antonio TX  78229-2263
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	5,7-dihydroxy-3-(4-hydroxyphenyl)-chromen-4-one
	Trade Name:
	Orphan Designation:
	Prevention of acute radiation syndrome
	Designation 
	6/18/2007	Sponsor and Address
	Marketing Exclusivity 	Humanetics, Inc.
	10400 Viking Drive
	Eden Prairie MN  55344 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	5-[(E)-2-(4-hydroxyphenyl)-ethenyl] benzene-1,3 diol
	Trade Name:
	Resveratrol	Orphan Designation:
	Treatment of MELAS syndrome
	Designation 
	3/13/2008	Sponsor and Address
	Marketing Exclusivity 	Sirtris Pharmaceuticals, Inc.
	200 Technology Square
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	506U78
	Trade Name:
	Orphan Designation:
	Treatment of chronic lymphocytic leukemia.
	Designation 
	9/2/1999	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline
	Five Moore Dr.
	P.O. Box 13398
	Research Triangle Park NC  27709-3398
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	5a8, monoclonal antibody to CD4
	Trade Name:
	Orphan Designation:
	For use in post-exposure prophylaxis for occupational exposure to human 
	immunodeficiency virus.
	Designation 
	12/20/1993	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	5-aza-2'-deoxycytidine
	Trade Name:
	Orphan Designation:
	Treatment of acute leukemia.
	Designation 
	8/3/1987	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	4140 Dublin Blvd.
	Suite 200
	Dublin CA  94568 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	5-hydroxymethyl-2-furfuraldehyde
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell disease
	Designation 
	5/26/2006	Sponsor and Address
	Marketing Exclusivity 	Xechem International, Inc.
	New Brunswick Technoloogy Center
	Building 1, Suite 310
	New Brunswick NJ  08901-3279
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	5-iodo-2-pytimidinone-2'-deoxyribose 
	Trade Name:
	Orphan Designation:
	Treatment of malginant glioma
	Designation 
	5/26/2006	Sponsor and Address
	Marketing Exclusivity 	Hana Biosciences, Inc.
	7000 Shoreline Court
	Suite 370
	South San Francisco CA  94080 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	5-methyl-1-phenyl-2-(1H)-pyridone(CAS 53179-13-8)
	Trade Name:
	Pirfenidone	Orphan Designation:
	Treatment of idiopathic pulmonary fibrosis
	Designation 
	3/5/2004	Sponsor and Address
	Marketing Exclusivity 	InterMune, Inc.
	3280 Bayshore Blvd
	Brisbane CA  94005 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	6 alpha-ethylchenodeoxycholic acid
	Trade Name:
	Orphan Designation:
	Treatment of primary biliary cirrhosis  
	Designation 
	4/9/2008	Sponsor and Address
	Marketing Exclusivity 	Intercept Pharmaceuticals, Inc.
	18 Desbrosses Street
	New York NY  10013 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	6,8-bis-benzylsulfanyl-octanoic acid
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	2/6/2006	Sponsor and Address
	Marketing Exclusivity 	Cornerstone Pharmaceuticals, Inc.
	25 Health Science Drive
	Stony Brook NY  11790 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	6-alpha-ethylchenodeoxycholic acid
	Trade Name:
	Orphan Designation:
	Treatment of primary sclerosing cholangitis
	Designation 
	4/9/2008	Sponsor and Address
	Marketing Exclusivity 	Intercept Pharmaceuticals, Inc.
	18 Desbrosses Street
	New York NY  10013 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	6-hydroxymethylacylfulvene
	Trade Name:
	Orphan Designation:
	Treatment of histologically confirmed advanced or metastatic pancreatic 
	cancer.
	Designation 
	4/6/1999	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma, Inc.
	5775 West Old Shakopee
	Suite 100
	Bloomington MN  55437-3107
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	8 Cyclopentyl 1,3-dipropylxanthine
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	3/24/1997	Sponsor and Address
	Marketing Exclusivity 	SciClone Pharmaceuticals, Inc.
	901 Mariner's Island Boulevard
	San Mateo CA  94404-1593
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	8-methoxsalen
	Trade Name:
	Uvadex	Orphan Designation:
	For use in conjunction with the UVAR photopheresis to treat diffuse systemic
	 sclerosis.
	Designation 
	6/22/1993	Sponsor and Address
	Marketing Exclusivity 	Therakos, Inc.
	Oaklands Corporate Center
	437 Creamery Way
	Exton PA  19341 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	8-methoxsalen
	Trade Name:
	Uvadex	Orphan Designation:
	For the prevention of acute rejection of cardiac allografts.
	Designation 
	5/12/1994	Sponsor and Address
	Marketing Exclusivity 	Therakos, Inc.
	Oaklands Corporate Center
	437 Creamery Way
	Exton PA  19341 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	90Y-hPAMA4
	Trade Name:
	PAN-Cide	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	9-cis-retinoic acid
	Trade Name:
	Orphan Designation:
	Prevention of retinal detachment due to proliferative vitreoretinopathy.
	Designation 
	1/2/1997	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92623-9534
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	9-nitro-20-(S)-camptothecin
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic cancer.
	Designation 
	9/16/1996	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	4140 Dublin Blvd.
	Suite 200
	Dublin CA  94568 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	9-nitro-20-(S)-camptothecin	Treatment of pediatric HIV-infection/AIDS patients
	Trade Name:
	Camvirex	Orphan Designation:
	Treatment of pediatric HIV infection/AIDS
	Designation 
	5/15/2001	Sponsor and Address
	Marketing Exclusivity 	NovoMed Pharmaceuticals, Inc.
	P.O. Box 900
	Germantown MD  20875-0900
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	a-(3-aminophthalimido) glutaramide
	Trade Name:
	Actimid	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	1/15/2003	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	7 Powder Horn Drive
	Warren NJ  07059 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	A10 & AS2-1 Antineoplaston
	Trade Name:
	Orphan Designation:
	Treatment for patients with brain stem glioma
	Designation 
	9/3/2004	Sponsor and Address
	Marketing Exclusivity 	Burzynski Research Institute, Inc.
	9432 Old Katy Road
	Houston TX  77055 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Abetimus
	Trade Name:
	Orphan Designation:
	Treatment of lupus nephritis.
	Designation 
	7/28/2000	Sponsor and Address
	Marketing Exclusivity 	La Jolla Pharmaceutical Co.
	6455 Nancy Ridge Dr.
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ACA125
	Trade Name:
	Orphan Designation:
	Treatment of epithelial ovarian cancer
	Designation 
	11/25/2003	Sponsor and Address
	Marketing Exclusivity 	Menarini Ricerche S.p.A.
	Via Tito Speri 10
	Pomezia Roma
	    
	ITALY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Acetylcysteine
	Trade Name:
	Mucomyst/Mucomyst 10 IV	Orphan Designation:
	Intravenous treatment of patients presenting with moderate to severe 
	acetaminophen overdose.
	Designation 
	8/13/1987	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Company
	P.O. Box 4500
	Princeton NJ  08543-4500
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	acetylcysteine	For the use of Acetadote(registered TM) Injection, administered 
	intravenously within 8 to 10 hours after ingestion of a potentially heptotoxic
	 quantity of acetaminophen, to prevent or lessen hepatic injur
	Trade Name:
	Acetadote	Orphan Designation:
	For the intravenous treatment of moderate to severe acetaminophen 
	overdose
	Designation 
	10/19/2001	Sponsor and Address
	Marketing Exclusivity 	Cumberland Pharmaceuticals, Inc.
	1/23/2004	209 10th Street South
	Suite 332
	Nashville TN  37203 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Acid sphingomyelinase
	Trade Name:
	Orphan Designation:
	Treatment of acid sphingomyelinase deficiency (Niemann-Pick disease).
	Designation 
	8/3/2000	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	500 Kendall Street
	Cambridge MA  02142 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Aconiazide
	Trade Name:
	Orphan Designation:
	Treatment of tuberculosis.
	Designation 
	6/20/1988	Sponsor and Address
	Marketing Exclusivity 	Lincoln Diagnostics
	P.O. Box 1128
	Decatur IL  62525 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Adalimumab
	Trade Name:
	Humira	Orphan Designation:
	Treatment of pediatric Crohn's disease.
	Designation 
	10/19/2006	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	200 Abbott Park Road
	Abbott Park IL  60064-6188
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Adalimumab	Treatment of Juvenile Idiopathic Arthritis
	Trade Name:
	Humira	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis
	Designation 
	3/21/2005	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	2/21/2008	200 Abbott Park Road
	Abbott Park IL  60064-6157
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Adeno-associated vector expressing the human 
	lipoprotein lipase protein
	Trade Name:
	Orphan Designation:
	Treatment of lipoprotein lipase deficiency
	Designation 
	5/21/2007	Sponsor and Address
	Marketing Exclusivity 	Amsterdam Molecular Therapeutics BV
	P. O. Box 22506

	NETHERLANDS
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Adeno-associated viral vector containing the gene for
	 human coagulation factor IX
	Trade Name:
	Coagulin-B	Orphan Designation:
	Intramuscular treatment of patients with moderate to severe hemophilia
	Designation 
	6/13/2001	Sponsor and Address
	Marketing Exclusivity 	Avigen, Inc.
	1301 Harbor Bay Parkway
	Alameda CA  94502 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Adeno-associated viral vector containing the gene for
	 human coagulation factor IX
	Trade Name:
	Coagulin-B	Orphan Designation:
	Intrahepatic treatment of patients with moderate to severe hemophilia
	Designation 
	6/13/2001	Sponsor and Address
	Marketing Exclusivity 	Avigen, Inc.
	1301 Harbor Bay Parkway
	Alameda CA  94502 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Adeno-associated viral vector expressing human acid
	 alpha glucosidase gene
	Trade Name:
	Orphan Designation:
	Treatment for Pompe disease
	Designation 
	3/20/2007	Sponsor and Address
	Marketing Exclusivity 	Applied Genetic Technologies Corporation
	11801 Research Drive
	Alachua FL  32615 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	adeno-associated viral vector expressing human 
	retinoschisin-1 gene
	Trade Name:
	Orphan Designation:
	Treatment of X-linked juvenile retinoschisis (XLRS).
	Designation 
	5/21/2007	Sponsor and Address
	Marketing Exclusivity 	Applied Genetic Technologies Corporation
	11801 Research Drive
	Alachua FL  32615 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Adeno-associated viral-based vector cystic fibrosis 
	gene therapy
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	2/15/1995	Sponsor and Address
	Marketing Exclusivity 	Targeted Genetics Corporation
	1100 Olive Way, Suite 100
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Adenosine
	Trade Name:
	Orphan Designation:
	For use in conjunction with BCNU in the treatment of brain tumors.
	Designation 
	8/1/1989	Sponsor and Address
	Marketing Exclusivity 	Medco Research, Inc.
	8455 Beverly Boulevard
	Suite 308
	Los Angeles CA  90048 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Adenoviral vector expressing Herpes simplex virus 
	thymidine kinase gene
	Trade Name:
	Orphan Designation:
	Treatment of malignant brain tumors
	Designation 
	6/17/2005	Sponsor and Address
	Marketing Exclusivity 	Advantagene, Inc.
	160 Paulson Road
	Waban MA  02468 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Adenovirus-based vector Factor VIII complementary 
	DNA to somatic cells
	Trade Name:
	MiniAdFVIII	Orphan Designation:
	Treatment of hemophilia A.
	Designation 
	12/15/1999	Sponsor and Address
	Marketing Exclusivity 	GenStar Therapeutics Corporation
	10835 Altman Row
	Suite 150
	San Diego CA  92121 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	adenovirus-mediated herpes simplex virus-thymidine 
	kinase gene
	Trade Name:
	Orphan Designation:
	Use with gancyclovir in the treatment of malignant glioma
	Designation 
	7/31/2001	Sponsor and Address
	Marketing Exclusivity 	Ark Therapeutics Ltd
	6 Warren Mews
	London W1T6AR
	London    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aerosolized pooled immune globulin
	Trade Name:
	Orphan Designation:
	Treatment of respiratory syncytial virus lower respiratory tract disease.
	Designation 
	1/3/1989	Sponsor and Address
	Marketing Exclusivity 	Pediatric Pharmaceuticals, Inc.
	718 Bradford Avenue
	Westfield NJ  07090 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	a-Galactosidase A
	Trade Name:
	Plant-Produced Human a-Glactosidase A	Orphan Designation:
	Treatment of Fabry's disease
	Designation 
	1/21/2003	Sponsor and Address
	Marketing Exclusivity 	Alpha Gal, LLC
	 a Kentucky Bioprocessing (KBP) subsidiary
	3700 Airpark Drive
	Owensboro KY  42301 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Aglycosyl anti-CD3 monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of new-onset type I diabetes mellitus
	Designation 
	2/6/2006	Sponsor and Address
	Marketing Exclusivity 	TolerRX, Inc.
	300 Technology Square
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	AI-RSA
	Trade Name:
	Orphan Designation:
	Treatment of autoimmune uveitis.
	Designation 
	10/8/1992	Sponsor and Address
	Marketing Exclusivity 	AutoImmune, Inc.
	128 Spring Street
	Lexington MA  02173 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Albendazole	Treatment of parenchymal neurocysticercosis due to active lesions caused 
	by larval forms of the pork tapeworm, Taenia solium.
	Trade Name:
	Albenza	Orphan Designation:
	Treatment of neurocysticercosis due to Taenia solium as: 1) chemotherapy 
	of parenchymal, subarachnoidal and racemose (cysts in spinal fluid) 
	Designation 	neurocysticercosis in symptomatic cases and 2) prophylaxis of epilepsy and 
	1/18/1996	other sequelae in asymptomatic neurocysticercosis.
	Sponsor and Address
	Marketing Exclusivity 	SmithKline Beecham Pharmaceuticals
	6/11/1996	One Franklin Plaza
	P.O. Box 7929
	Philadelphia PA  19101 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Albendazole	Treatment of cystic hydatid disease of the liver, lung, and peritoneum, 
	caused by the larval form of the dog tapeworm, Echinococcus granulosus.
	Trade Name:
	Albenza	Orphan Designation:
	Treatment of hydatid disease (cystic echinococcosis due to E. granulosus 
	larvae or alveolar echinococcosis due to E. multilocularis larvae).
	Designation 
	1/17/1996	Sponsor and Address
	Marketing Exclusivity 	SmithKline Beecham Pharmaceuticals
	6/11/1996	One Franklin Plaza
	P.O. Box 7929
	Philadelphia PA  19101 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Albuterol
	Trade Name:
	Orphan Designation:
	Prevention of  paralysis due to spinal cord injury
	Designation 
	3/12/2002	Sponsor and Address
	Marketing Exclusivity 	MotoGen, Inc.
	3 Pine View Road
	Mount Kisco NY  10549 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Aldesleukin
	Trade Name:
	Proleukin	Orphan Designation:
	Treatment of primary immunodeficiency disease associated with T-cell 
	defects.
	Designation 
	3/22/1989	Sponsor and Address
	Marketing Exclusivity 	Chiron Corporation
	4560 Horton Street
	Emeryville CA  94608-2916
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aldesleukin	Treatment of adults (>18 years old) with metastatic renal cell carcinoma.
	Trade Name:
	Proleukin	Orphan Designation:
	Treatment of metastatic renal cell carcinoma.
	Designation 
	9/14/1988	Sponsor and Address
	Marketing Exclusivity 	Chiron Corporation
	5/5/1992	4560 Horton Street
	Emeryville CA  94608-2916
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aldesleukin	Treatment of adults with metastatic melanoma.
	Trade Name:
	Proleukin	Orphan Designation:
	Treatment of metastatic melanoma.
	Designation 
	9/10/1996	Sponsor and Address
	Marketing Exclusivity 	Chiron Corporation
	1/9/1998	4560 Horton Street
	Emeryville CA  94608-2916
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aldesleukin
	Trade Name:
	Proleukin	Orphan Designation:
	Treatment of acute myelogenous leukemia.
	Designation 
	7/31/1998	Sponsor and Address
	Marketing Exclusivity 	Chiron Corporation
	4560 Horton St.
	Emeryville CA  94608-2916
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aldesleukin
	Trade Name:
	Proleukin	Orphan Designation:
	For the treatment non-Hodgkin's lymphoma.
	Designation 
	11/24/1998	Sponsor and Address
	Marketing Exclusivity 	Chiron Corporation
	4560 Horton St.
	Emeryville CA  94608-2916
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Alefacept
	Trade Name:
	Amevive	Orphan Designation:
	For use as prophylaxis of rejection in patients receiving allogenic solid 
	organ transplants.
	Designation 
	12/19/2007	Sponsor and Address
	Marketing Exclusivity 	Astellas Pharma US, Inc.
	Three Parkway North
	Deerfield IL  60015-2548
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	alemtuzumab	The treatment of patients with B-cell chronic lymphocytic leukemia who 
	have been treated with alkylating agents and who have failed fludarabine 
	therapy.
	Trade Name:
	Campath	Orphan Designation:
	Treatment of chronic lymphocytic leukemia.
	Designation 
	10/20/1997	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	5/7/2001	4545 Horizon Hill Blvd.
	San Antonio TX  78229-2263
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	alendronate
	Trade Name:
	Fosamax	Orphan Designation:
	Treatment of osteogenesis imperfecta in pediatric patients 4 years of age 
	and older
	Designation 
	3/31/2003	Sponsor and Address
	Marketing Exclusivity 	Merck & Co., Inc.
	126 East Lincoln Ave.
	Rahway NJ  07065-0900
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alendronate disodium
	Trade Name:
	Fosamax	Orphan Designation:
	Treatment of the bone manifestations of Gaucher disease
	Designation 
	2/13/2001	Sponsor and Address
	Marketing Exclusivity 	Richard J. Wenstrup, M.D.
	Division of Human Genetics
	Children's Hospital Research Foundation
	Cincinnati OH  45229-3039
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alfentanil
	Trade Name:
	Orphan Designation:
	Management of postherpetic neuralgia
	Designation 
	7/8/2005	Sponsor and Address
	Marketing Exclusivity 	Cinergen, LLC
	146 Medinah Drive
	Blue Bell PA  19422-3212
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Alfentanil
	Trade Name:
	Orphan Designation:
	Treatment of painful HIV-associated neuropathy
	Designation 
	8/9/2005	Sponsor and Address
	Marketing Exclusivity 	Cinergen, LLC
	146 Medinah Drive
	Blue Bell PA  19422-3212
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alglucerase injection
	Trade Name:
	Ceredase	Orphan Designation:
	Replacement therapy in patients with Type II and III Gaucher's disease.
	Designation 
	7/21/1995	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alglucerase injection	Long-term enzyme replacement therapy for children, adolescents and adult
	 patients with a confirmed diagnosis of Type I Gaucher disease who
	exhibit signs and symptoms that are severe enough to result in one or more 
	Trade Name:	of the following conditions:
	a) moderate-to-severe anemia;
	b) thrombocytopenia with bleeding tendency;
	c) bone disease;
	d) significant hepatomegaly or splenomegaly.
	Ceredase	Orphan Designation:
	For replacement therapy in patients with Gaucher's disease type I.
	Designation 
	3/11/1985	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	4/5/1991	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alitretinoin	Topical treatment of cutaneous lesions in patients with AIDS-related 
	Kaposi's sarcoma.
	Trade Name:
	Panretin	Orphan Designation:
	Treatment of AIDS-related Kaposi's sarcoma.
	Designation 
	3/24/1998	Sponsor and Address
	Marketing Exclusivity 	Eisai Medical Research, Inc
	2/2/1999	55 Challenger Road
	Ridgefield Park NJ  07660 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alitretinoin
	Trade Name:
	Panretin	Orphan Designation:
	Treatment of acute promyelocytic leukemia
	Designation 
	4/10/1992	Sponsor and Address
	Marketing Exclusivity 	Ligand Pharmaceuticals, Inc.
	10275 Science Center Dr.
	San Diego CA  92121-1117
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	allantoin
	Trade Name:
	Alwextin	Orphan Designation:
	Treatment of skin blistering and erosions associated with inherited 
	epidermolysis bullosa
	Designation 
	11/21/2002	Sponsor and Address
	Marketing Exclusivity 	Alwyn Company, Inc.
	2301 Highway 60 East
	Lake Crystal MN  56055 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Allogeneic human retinal pigment epithelial cells on
	 gelatin microcarriers
	Trade Name:
	Spheramine	Orphan Designation:
	Treatment of Hoehn and Yahr stage 3 and 4 Parkinson's disease.
	Designation 
	7/18/1997	Sponsor and Address
	Marketing Exclusivity 	Bayer Healthcare Pharmaceuticals, Inc.
	Post Office Box 1000
	50 Division Street, Suite 503
	Montville NJ  07045-1000
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Allogeneic peripheral blood mononuclear cells 
	sensitized against patient alloantigens by mixed 
	Trade Name:
	CYTOIMPLANT	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	6/13/1997	Sponsor and Address
	Marketing Exclusivity 	Applied Immunotherapeutics, LLC
	14132 E. Firestone Boulevard
	Santa Fe Springs CA  90670 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Allogeneic retinal epithelial cells transfected with 
	plasmid vector expressing ciliary neurotrophic growth 
	Trade Name:
	Orphan Designation:
	Treatment of retinitis pigmentosa
	Designation 
	9/1/2004	Sponsor and Address
	Marketing Exclusivity 	Neurotech USA, Inc.
	6 Blackstone Valley Place
	Lincoln RI  02865 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Allogeneic T-cells cultured with anti-CD3 and IL-2; 
	transduced with retroviral vector (SFCMM-3), 
	expressing herpes simplex 1 virus-thymidine kinase 
	(HSV-TK) and truncated low affinity nerve growth 
	factor receptor; selected with anti-low affinity nerve gro
	Trade Name:
	Orphan Designation:
	Immunotherapy for acceleration of T-cell reconstitution in patients 
	undergoing allogeneic hematopoietic stem cell transplantation
	Designation 
	1/28/2005	Sponsor and Address
	Marketing Exclusivity 	MolMed S.p.A.
	Via Olgettina 58
	Milan   20132 
	 
	ITALY
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Allopurinol riboside
	Trade Name:
	Orphan Designation:
	Treatment of cutaneous and visceral leishmaniasis.
	Designation 
	12/4/1985	Sponsor and Address
	Marketing Exclusivity 	Burroughs Wellcome Company
	3030 Cornwallis Road
	P.O. Box 12700
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Allopurinol riboside
	Trade Name:
	Orphan Designation:
	Treatment of Chagas' disease.
	Designation 
	12/4/1985	Sponsor and Address
	Marketing Exclusivity 	Burroughs Wellcome Company
	3030 Cornwallis Road
	P.O. Box 12700
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Allopurinol sodium	Management of patients with leukemia, lymphoma, and solid tumor 
	malignancies who are receiving cancer therapy which causes elevations of 
	serum and urinary uric acid levels and who cannot tolerate oral therapy.
	Trade Name:
	Aloprim for Injection	Orphan Designation:
	Management of patients with leukemia, lymphoma, and solid tumor 
	malignancies who are receiving cancer therapy which causes elevations of 
	Designation 	serum and urinary uric acid levels and who cannot tolerate oral therapy.
	10/16/1992	Sponsor and Address
	Marketing Exclusivity 	Catalytica Pharmaceuticals, Inc
	5/17/1996	PO Box 1887
	Greenville NC  27835-1887
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Allopurinol sodium
	Trade Name:
	Orphan Designation:
	Ex-vivo preservation of cadaveric kidneys for transplantation
	Designation 
	11/9/1987	Sponsor and Address
	Marketing Exclusivity 	Burroughs Wellcome Company
	3030 Cornwallis Road
	Research Triangle Pk NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alpha-1-acid glycoprotein
	Trade Name:
	Orphan Designation:
	Treatment of cocaine overdose
	Designation 
	3/5/2004	Sponsor and Address
	Marketing Exclusivity 	Bio Products Laboratory
	Dagger Lane, Elstree, Hertfordshire
	WD6 3BX
	    
	UNITED KINGDOM
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Alpha-1-acid glycoprotein
	Trade Name:
	Orphan Designation:
	Treatment of tricyclic antidepressant poisoning
	Designation 
	3/17/2004	Sponsor and Address
	Marketing Exclusivity 	Bio Products Laboratory
	Dagger Lane
	Elstree, Hertfordshire
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alpha-1-antitrypsin (recombinant DNA Origin)
	Trade Name:
	Orphan Designation:
	As supplementation therapy for alpha-1-antitrypsin deficiency in the ZZ 
	phenotype population.
	Designation 
	1/1/1984	Sponsor and Address
	Marketing Exclusivity 	Chiron Corporation
	4560 Horton Street
	Emeryville CA  94608-2916
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alpha1-antitrypsin(human)
	Trade Name:
	Orphan Designation:
	Treatment of bronchiectasis
	Designation 
	4/3/2008	Sponsor and Address
	Marketing Exclusivity 	Kamada, Ltd.
	7 Sapir Street 
	Ness Ziona    
	 
	ISRAEL
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alpha1-Proteinase Inhibitor (Human) 
	Trade Name:
	Orphan Designation:
	Inhalation therapy for the the treatment of congential deficiency of alpha1-
	proteinase inhibitor.
	Designation 
	12/22/2004	Sponsor and Address
	Marketing Exclusivity 	Kamada Ltd.
	Kiryat Weizmann

	ISRAEL
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alpha1-Proteinase Inhibitor (Human) 
	Trade Name:
	ARC-API	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	9/1/2004	Sponsor and Address
	Marketing Exclusivity 	Kamada Ltd.
	Kiryat Weizmann

	ISRAEL
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Alpha1-proteinase inhibitor (human)
	Trade Name:
	Orphan Designation:
	For slowing the progression of emphysema in alpha1-antitrypsin deficient 
	patients.   
	Designation 
	11/24/1999	Sponsor and Address
	Marketing Exclusivity 	CSL Behring L.L.C.
	1020 First Ave.
	PO Box 61501
	King of Prussia PA  19406-0901
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alpha1-proteinase inhibitor (human)	For chronic replacement therapy of individuals having congenital 
	deficiency of alpha1- proteinase inhibitor with clinically demonstrable 
	panacinar emphysema.
	Trade Name:
	Prolastin	Orphan Designation:
	For replacement therapy in the alpha-1-proteinase inhibitor congenital 
	deficiency state.
	Designation 
	12/7/1984	Sponsor and Address
	Marketing Exclusivity 	Bayer Corporation
	12/2/1987	Pharmaceutical Division, Biological Products
	400 Morgan Lane
	New Haven CT  06516 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alpha-galactosidase A
	Trade Name:
	Fabrase	Orphan Designation:
	Treatment of Fabry's disease.
	Designation 
	7/20/1990	Sponsor and Address
	Marketing Exclusivity 	Desnick, Robert J. M.D.
	The Mount Sinai School Of Medicine
	Fifth Avenue at 100th Street, Box 1203
	New York NY  10029 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alpha-galactosidase A
	Trade Name:
	CC-galactosidase	Orphan Designation:
	Treatment of alpha-galactosidase A deficiency (Fabry's disease).
	Designation 
	6/17/1991	Sponsor and Address
	Marketing Exclusivity 	David Calhoun, Ph.D.
	Department of Chemistry
	Convent Avenue & 138th Street
	New York NY  10031 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alpha-galactosidase A
	Trade Name:
	Replagal	Orphan Designation:
	Long-term enzyme replacement therapy for the treatment of Fabry disease.  
	Designation 
	6/22/1998	Sponsor and Address
	Marketing Exclusivity 	 Shire Human Genetic Therapies, Inc.
	700 Main Street
	Cambridge MA  02139 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Alpha-melanocyte stimulating hormone
	Trade Name:
	Orphan Designation:
	Prevention and treatment of intrinsic acute renal failure due to ischemia.
	Designation 
	8/19/1997	Sponsor and Address
	Marketing Exclusivity 	National Institute of Diabetes, and Digestive and Kidney Diseases
	National Institutes of Health, 31 Center Drive MSC
	Building 31, Room 9N-222
	Bethesda MD  20892-2560
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alpha-tocopherol quinone
	Trade Name:
	Orphan Designation:
	Treatment of inherited mitochondrial respiratory chain diseases
	Designation 
	3/28/2006	Sponsor and Address
	Marketing Exclusivity 	Penwest Pharmaceuticals Company
	39 Old Ridgebury Road
	Suite 11
	Danbury CT  06810 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alprostadil
	Trade Name:
	Orphan Designation:
	Treatment of severe peripheral arterial occlusive disease (critical limb 
	ischemia) in patients where other procedures, grafts or angioplasty, are not 
	Designation 	indicated.
	10/20/1993	Sponsor and Address
	Marketing Exclusivity 	Schwarz Pharma, Inc.
	P.O. Box 2038
	Milwaukee WI  53201 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	alteplase
	Trade Name:
	Activase	Orphan Designation:
	Treatment of intraventricular hemmorage associated with intracerebral 
	hemmorrhage
	Designation 
	1/27/2003	Sponsor and Address
	Marketing Exclusivity 	Daniel F. Hanley, MD
	Johns Hopkins University
	600 N. Wolfe St., Jefferson 1-109
	Baltimore MD  21287 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Altretamine	Single agent palliative treatment of patients with persistent or recurrent 
	ovarian cancer following first-line therapy with a cisplatin and/or alkylating 
	agent based combination.
	Trade Name:
	Hexalen	Orphan Designation:
	Treatment of advanced adenocarcinoma of the ovary.
	Designation 
	2/9/1984	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	12/26/1990	One Tower Bridge
	100 Front Street, Suite 400
	Conshohocken PA  19428 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Alvocidib
	Trade Name:
	Orphan Designation:
	Teatment of B-cell chronic lymphocytic leukemia (B-CLL) or prolymphocytic
	 leukemia arising from CLL.
	Designation 
	4/13/2007	Sponsor and Address
	Marketing Exclusivity 	Sanofi-Aventis US, Inc.
	55 Corporate Drive
	Bridgewater NJ  08807 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ambrisentan	Treatment of pulmonary arterial hypertension (WHO group I) in patients 
	with WHO class II or III symptoms to improve exercise capacity and delay 
	clinical worsening
	Trade Name:
	Letairis	Orphan Designation:
	Treatment of pulmonary arterial hypertension 
	Designation 
	7/16/2004	Sponsor and Address
	Marketing Exclusivity 	Gilead Colorado
	6/15/2007	7575 West 103rd Avenue
	Suite 102
	Westminister CO  80021-5426
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	AMG 531
	Trade Name:
	Orphan Designation:
	Treatment of thrombocytopenia associated with myelodysplasia syndrome
	Designation 
	10/31/2007	Sponsor and Address
	Marketing Exclusivity 	Amgen Inc.
	One Amgen Center Drive
	Thousand Oaks CA  91320-1799
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	AMG 531
	Trade Name:
	Orphan Designation:
	Treatment of immune thrombocytopenic purpura
	Designation 
	3/27/2003	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	One Amgen Center Drive
	Thousand Oaks CA  91320-1799
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amifostine
	Trade Name:
	Ethyol	Orphan Designation:
	Treatment of myelodysplastic syndromes.  
	Designation 
	10/4/1999	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Amifostine
	Trade Name:
	Ethyol	Orphan Designation:
	For use as a chemoprotective agent for cisplatin in the treatment of 
	metastatic melanoma.
	Designation 
	5/30/1990	Sponsor and Address
	Marketing Exclusivity 	Medimmune LLC
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amifostine
	Trade Name:
	Ethyol	Orphan Designation:
	For use as a chemoprotective agent for cyclophosphamide in the treatment 
	of advanced ovarian carcinoma.
	Designation 
	5/30/1990	Sponsor and Address
	Marketing Exclusivity 	Medimmune, LLC 
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amifostine	To reduce the cumulative renal toxicity associated with repeated 
	administration of cisplatin in patients with advanced ovarian cancer.
	Trade Name:
	Ethyol	Orphan Designation:
	For use as a chemoprotective agent for cisplatin in the treatment of 
	advanced ovarian carcinoma.
	Designation 
	5/30/1990	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	12/8/1995	One Tower Bridge
	100 Front Street, Suite 400
	West Conshohocken PA  19428 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amifostine	Reduction of the incidence of moderate to severe xerostomia in patients 
	undergoing post-operative radiation treatment for head and neck cancer, 
	where the radiation port includes a substantial portion of the parotid glands. 
	Trade Name:
	Ethyol	Orphan Designation:
	Reduction of the incidence of moderate to severe xerostomia in patients 
	undergoing post-operative radiation treatment for head and neck cancer.
	Designation 
	5/12/1998	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	6/24/1999	One Tower Bridge
	100 Front Street, Suite 400
	Conshohocken PA  19428 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amifostine
	Trade Name:
	Ethyol	Orphan Designation:
	For the reduction of the incidence and severity of toxicities associated with 
	cisplatin administration.  
	Designation 
	11/24/1998	Sponsor and Address
	Marketing Exclusivity 	Medimmune LLC
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Amikacin
	Trade Name:
	SLIT  Amikacin	Orphan Designation:
	Treatment of bronchopulmonary Pseudomonas aeruginosa infections in 
	cystic fibrosis patients
	Designation 
	3/9/2006	Sponsor and Address
	Marketing Exclusivity 	Transave, Inc.
	11 Deer Park Drive
	Monmouth Junction NJ  08852-1923
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amiloride HCl solution for inhalation
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	7/18/1990	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Research and Development
	5 Moore Drive
	PO Box 13398
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aminocaproic acid
	Trade Name:
	Caprogel	Orphan Designation:
	For the topical treatment of traumatic hyphema of the eye.
	Designation 
	1/6/1995	Sponsor and Address
	Marketing Exclusivity 	Eastern Virginia Medical School
	Department of Ophthalomology
	880 Kempsville Road, Suite 2500
	Norfolk VA  23502-3990
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aminolevlinic acid hydrochloride
	Trade Name:
	Levulan	Orphan Designation:
	Treatment of esophageal dysplasia
	Designation 
	3/20/2007	Sponsor and Address
	Marketing Exclusivity 	DUSA Pharmaceuticals, Inc.
	25 Upton Drive
	Wilmington MA  01887 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aminosalicylate sodium
	Trade Name:
	Orphan Designation:
	Treatment of Crohn's disease.
	Designation 
	4/6/1993	Sponsor and Address
	Marketing Exclusivity 	Syncom Pharmaceuticals, Inc.
	66 Hanover Road
	Florham Park NJ  07932 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Aminosalicylic acid	Treatment of tuberculosis
	Trade Name:
	Paser Granules	Orphan Designation:
	Treatment of tuberculosis infections
	Designation 
	2/19/1992	Sponsor and Address
	Marketing Exclusivity 	Jacobus Pharmaceutical Company
	6/30/1994	37 Cleveland Lane
	P.O. Box 5290
	Princeton NJ  08540 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aminosidine 
	Trade Name:
	Paromomycin	Orphan Designation:
	Treatment of visceral leishmaniasis
	Designation 
	3/29/2005	Sponsor and Address
	Marketing Exclusivity 	The Institute for One World Health
	580 California Street
	San Francisco CA  94104 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aminosidine
	Trade Name:
	Paromomycin	Orphan Designation:
	Treatment of visceral leishmaniasis (kala-azar).
	Designation 
	9/9/1994	Sponsor and Address
	Marketing Exclusivity 	Kanyok, Thomas P. Pharm.D.
	University of Illinois at Chicago College of Pharm
	833 South Wood Street (m/c886) Rm. 176
	Chicago IL  60612 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aminosidine
	Trade Name:
	Gabbromicina	Orphan Designation:
	Treatment of tuberculosis.
	Designation 
	5/14/1993	Sponsor and Address
	Marketing Exclusivity 	Kanyok, Thomas P. Pharm.D.
	University Of Illinois At Chicago College of Pharm
	833 South Wood Street (m/c886) Rm. 176
	Chicago IL  60612 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aminosidine
	Trade Name:
	Gabbromicina	Orphan Designation:
	Treatment of Mycobacterium avium complex.
	Designation 
	11/15/1993	Sponsor and Address
	Marketing Exclusivity 	Kanyok, Thomas P. Pharm.D.
	University of Illinois at Chicago College of Pharm
	833 South Wood Street (m/c886) Rm. 176
	Chicago IL  60612 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Amiodarone
	Trade Name:
	Amio-Aqueous	Orphan Designation:
	Treatment of incessant ventricular tachycardia.
	Designation 
	8/17/1993	Sponsor and Address
	Marketing Exclusivity 	Academic Pharmaceuticals, Inc.
	21 N. Skokie Valley Highway
	Suite G3
	Lake Bluff IL  60044 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amiodarone HCl	For initiation of treatment and prophylaxis of frequently recurring ventricular
	 fibrillation and hemodynamically unstable ventricular tachycardia in 
	patients refractory to other therapy.
	Trade Name:
	Cordarone	Orphan Designation:
	For the acute treatment and prophylaxis of life-threatening ventricular 
	tachycardia or ventricular fibrillation.
	Designation 
	3/16/1994	Sponsor and Address
	Marketing Exclusivity 	Wyeth-Ayerst Laboratories
	8/3/1995	P.O. Box 8299
	Philadelphia PA  19101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ammonium tetrathiomolybdate
	Trade Name:
	Orphan Designation:
	Treatment of idiopathic pulmonary fibrosis
	Designation 
	5/5/2008	Sponsor and Address
	Marketing Exclusivity 	Pipex Pharmaceuticals, Inc.
	3930 Varsity Drive
	Ann Arbor MI  48108 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ammonium tetrathiomolybdate
	Trade Name:
	Coprexa	Orphan Designation:
	Treatment of Wilson's disease.
	Designation 
	1/31/1994	Sponsor and Address
	Marketing Exclusivity 	Pipex Pharmaceuticals, Inc.
	3930 Varsity Drive
	Ann Arbor MI  48108 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amonafide L-malate
	Trade Name:
	Xanafide	Orphan Designation:
	Treatment of acute myeloid leukemia
	Designation 
	12/20/2006	Sponsor and Address
	Marketing Exclusivity 	Xanthus Pharmaceuticals, Inc.
	300 Technology Square
	Cambridge MA  02139 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Amphotericin B inhalation powder
	Trade Name:
	Orphan Designation:
	Prevention of pulmonary fungal infections in patients at risk for aspergillosis
	 due to immunosuppressive therapy including those receiving organ or stem
	Designation 	 cell transplants, or teated with chemotherapy or radiation for hematologic 
	12/15/2005	malignancies
	Sponsor and Address
	Marketing Exclusivity 	Nektar Therapeutics
	201 Industrial Road
	San Carlos CA  94070-6256
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amphotericin B lipid complex
	Trade Name:
	Abelcet	Orphan Designation:
	Treatment of invasive protothecosis.
	Designation 
	8/21/1996	Sponsor and Address
	Marketing Exclusivity 	The Liposome Company, Inc.
	One Research Way
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amphotericin B lipid complex
	Trade Name:
	Abelcet	Orphan Designation:
	Treatment of invasive sporotrichosis.
	Designation 
	9/23/1996	Sponsor and Address
	Marketing Exclusivity 	The Liposome Company, Inc.
	One Research Way
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amphotericin B lipid complex
	Trade Name:
	Abelcet	Orphan Designation:
	Treatment of invasive coccidioidomycosis.
	Designation 
	5/6/1996	Sponsor and Address
	Marketing Exclusivity 	The Liposome Company, Inc.
	One Research Way
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amphotericin B lipid complex
	Trade Name:
	Abelcet	Orphan Designation:
	Treatment of invasive zygomycosis.
	Designation 
	5/6/1996	Sponsor and Address
	Marketing Exclusivity 	The Liposome Company, Inc.
	One Research Way
	Princeton NJ  08540 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Amphotericin B lipid complex
	Trade Name:
	Abelcet	Orphan Designation:
	Treatment of invasive candidiasis.
	Designation 
	6/27/1996	Sponsor and Address
	Marketing Exclusivity 	The Liposome Company, Inc.
	One Research Way
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amphotericin B lipid complex	Treatment of invasive fungal infections in patients who are refractory to or 
	intolerant of conventional amphotericin B therapy.
	Trade Name:
	Abelcet	Orphan Designation:
	Treatment of invasive fungal infections.
	Designation 
	12/5/1991	Sponsor and Address
	Marketing Exclusivity 	Liposome Company, Inc.
	10/18/1996	One Research Way
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	amrubicin
	Trade Name:
	Orphan Designation:
	Treatment of small cell lung cancer
	Designation 
	3/10/2008	Sponsor and Address
	Marketing Exclusivity 	Pharmion Corporation
	2525 28th Street
	Boulder CO  80301 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amsacrine
	Trade Name:
	Amsidyl	Orphan Designation:
	Treatment of acute adult leukemia.
	Designation 
	12/7/1984	Sponsor and Address
	Marketing Exclusivity 	Warner-Lambert Company
	Parke-Davis Pharmaceutical Research Division
	2800 Plymouth Road
	Ann Arbor MI  48106 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amyl nitrite, sodium nitrite, sodium thiosulfate
	Trade Name:
	Cyanide Antidote Kit	Orphan Designation:
	Treatment of cyanide poisoning
	Designation 
	12/18/2006	Sponsor and Address
	Marketing Exclusivity 	Akorn, Inc.
	2500 Millbrook Drive
	Buffalo Grove IL  60089 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Anagrelide
	Trade Name:
	Agrylin	Orphan Designation:
	Treatment of thrombocytosis in chronic myelogenous leukemia.
	Designation 
	7/14/1986	Sponsor and Address
	Marketing Exclusivity 	Roberts Pharmaceutical Corp.
	Meridian Center II
	4 Industrial Way West
	Eatontown NJ  07724-2274
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anagrelide	Treatment of patients with essential thrombocythemia to reduce the 
	elevated platelet count and the risk of thrombosis and to ameliorate 
	associated symptoms.
	Trade Name:
	Agrylin	Orphan Designation:
	Treatment of essential thrombocythemia.
	Designation 
	1/27/1988	Sponsor and Address
	Marketing Exclusivity 	Roberts Pharmaceutical Corp.
	3/14/1997	Meridian Center III
	6 Industrial Way West
	Eatontown NJ  07724 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anagrelide
	Trade Name:
	Agrylin	Orphan Designation:
	Treatment of polycythemia vera.
	Designation 
	6/11/1985	Sponsor and Address
	Marketing Exclusivity 	Roberts Pharmaceutical Corp.
	Meridian Center II
	4 Industrial Way West
	Eatontown NJ  07724-2274
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ananain, comosain
	Trade Name:
	Vianain	Orphan Designation:
	For the enzymatic debridement of severe burns.
	Designation 
	1/21/1992	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	One Kendall Square
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anaritide acetate
	Trade Name:
	Auriculin	Orphan Designation:
	Treatment of patients with acute renal failure.
	Designation 
	8/27/1992	Sponsor and Address
	Marketing Exclusivity 	Scios, Inc.
	2450 Bayshore Parkway
	Mountain View CA  94043 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Anaritide acetate
	Trade Name:
	Auriculin	Orphan Designation:
	Improvement of early renal allograft function following renal 
	transplantation.
	Designation 
	4/10/1992	Sponsor and Address
	Marketing Exclusivity 	Scios, Inc.
	2450 Bayshore Parkway
	Mountain View CA  94043 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anatibant
	Trade Name:
	Orphan Designation:
	Treatment of patients having experienced a severe traumatic brain injury 
	(Glasgow Coma Scale 3 to 8) in order to decrease early mortality and 
	Designation 	improve long-term functional and neurological outcome
	4/15/2005	Sponsor and Address
	Marketing Exclusivity 	Xytis, Inc.
	400 South El Camino Real
	Suite 1200
	San Mateo CA  94402-1703
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ancrod
	Trade Name:
	Viprinex	Orphan Designation:
	To establish and maintain anticoagulation in heparin-intolerant patients 
	undergoing cardiopulmonary bypass.
	Designation 
	10/20/1989	Sponsor and Address
	Marketing Exclusivity 	Knoll Pharmaceutical Company
	3000 Continental Dr., North
	Mt. Olive NJ  07828 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Angiotensin 1-7
	Trade Name:
	MARstem	Orphan Designation:
	Treatment of myelodysplastic syndrome
	Designation 
	8/3/2001	Sponsor and Address
	Marketing Exclusivity 	Maret Pharmaceutical Corporation
	4041 MacArthur Boulevard, Suite 375
	Newport Beach CA  92660 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Angiotensin 1-7
	Trade Name:
	Orphan Designation:
	Treatment of neutropenia associated with autologous bone marrow 
	transplantation.  
	Designation 
	2/16/2000	Sponsor and Address
	Marketing Exclusivity 	Maret Pharmaceuticals
	4041 MacArthur Blvd.
	Suite 375
	Newport Beach CA  92660 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Anti pan T lymphocyte monoclonal antibody
	Trade Name:
	Anti-t Lymphocyte Immunotoxin Xmmly-h65-rta	Orphan Designation:
	For ex-vivo treatment to eliminate mature T cells from potential bone 
	marrow grafts.
	Designation 
	1/29/1986	Sponsor and Address
	Marketing Exclusivity 	Xoma Corporation
	2910 Seventh Street
	Berkeley CA  94710 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anti pan T lymphocyte monoclonal antibody
	Trade Name:
	Anti-t Lymphocyte Immunotoxin Xmmly-h65-rta	Orphan Designation:
	For in-vivo treatment of bone marrow recipients to prevent graft rejection 
	and graft versus host disease.
	Designation 
	1/29/1986	Sponsor and Address
	Marketing Exclusivity 	Xoma Corporation
	2910 Seventh Street
	Berkeley CA  94710 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	antiangiogenic components extracted from marine 
	cartilage
	Trade Name:
	Neovastat (AE-941)	Orphan Designation:
	Treatment of renal cell carcinoma
	Designation 
	10/16/2002	Sponsor and Address
	Marketing Exclusivity 	AEterna Zentaris, Inc.
	Dr. Claude Hariton
	Chief Medical Officer, VP, Cli
	Quebec G1P 4P5, Canada    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	anti-CD23 IgG1, kappa monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	2/12/2003	Sponsor and Address
	Marketing Exclusivity 	Biogen IDEC, Inc.
	5200 Research Place
	San Diego CA  92122 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anti-CD40 mAb
	Trade Name:
	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	10/6/2005	Sponsor and Address
	Marketing Exclusivity 	Seattle Genetics, Inc.
	21823 30th Drive Southeast
	Bothell WA  98021 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Anti-CD45 monoclonal antibodies
	Trade Name:
	Orphan Designation:
	Prevention of acute graft rejection of human organ transplants.
	Designation 
	9/10/1990	Sponsor and Address
	Marketing Exclusivity 	Baxter Healthcare Corporation
	1620 Waukegan Road
	Mcgaw Park IL  60085 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anti-CEA Sheep-human chimeric monoclonal 
	antibody labeled w/iodine-131 (KAb201)
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	5/21/2003	Sponsor and Address
	Marketing Exclusivity 	Xenova Biomedix Limited CELTIC PHARMA
	957 Buckingham Avenue
	Berkshire SL1 4NL
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anti-cytomegalovirus monoclonal antibodies
	Trade Name:
	Orphan Designation:
	Prevention of human cytomegalovirus infection in bone marrow and organ 
	transplant patients.
	Designation 
	5/2/1990	Sponsor and Address
	Marketing Exclusivity 	Biomedical Research Institute
	345 North Smith Avenue
	St. Paul MN  55102 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anti-cytomegalovirus monoclonal antibodies
	Trade Name:
	Orphan Designation:
	Treatment of human cytomegalovirus infection in bone marrow and organ 
	transplant patients.
	Designation 
	5/2/1990	Sponsor and Address
	Marketing Exclusivity 	Biomedical Research Institute
	345 North Smith Avenue
	St. Paul MN  55102 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anti-cytomegalovirus monoclonal antibodies
	Trade Name:
	Orphan Designation:
	Prevention of human cytomegalovirus infection in patients diagnosed with 
	AIDS.
	Designation 
	5/3/1990	Sponsor and Address
	Marketing Exclusivity 	Biomedical Research Institute
	345 North Smith Avenue
	St. Paul MN  55102 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Anti-cytomegalovirus monoclonal antibodies
	Trade Name:
	Orphan Designation:
	Treatment of human cytomegalovirus infection in patients diagnosed with 
	AIDS.
	Designation 
	5/3/1990	Sponsor and Address
	Marketing Exclusivity 	Biomedical Research Institute
	345 North Smith Avenue
	St. Paul MN  55102 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anti-cytotoxic T lymphocyte antigen 4 monoclonal 
	antibody
	Trade Name:
	Orphan Designation:
	Treatment of stage IIb to stage IV metastatic melanoma
	Designation 
	9/18/2006	Sponsor and Address
	Marketing Exclusivity 	Pfizer Global Research & Development
	50 Pequot Avenue
	New London CT  06320 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antiepilepsirine
	Trade Name:
	Orphan Designation:
	Treatment of drug resistant generalized tonic-clonic epilepsy in children 
	and adults.
	Designation 
	3/23/1989	Sponsor and Address
	Marketing Exclusivity 	Children's Hospital
	700 Children's Drive
	Columbus OH  43205 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antihemophilic factor (human)	For surgical and/or invasive procedures in patients with von Willebrand 
	Disease (VWD) in whom desmopressin is either ineffective or 
	contraindicated.  It is not indicated for patients with severe VWD (Type 3) 
	Trade Name:	undergoing major surgery
	Alphanate	Orphan Designation:
	Treatment of von Willebrand's disease
	Designation 
	1/5/1996	Sponsor and Address
	Marketing Exclusivity 	Grifols Biologicals Inc.
	1/31/2007	5555 Valley Boulevard
	Los Angeles CA  90032-3548
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antihemophilic factor (recombinant)
	Trade Name:
	ReFacto	Orphan Designation:
	For the control and prevention of hemorrhagic episodes and for surgical 
	prophylaxis in patients with hemophilia A (congenital factor VIII deficiency 
	Designation 	or classic hemophilia).
	2/8/1996	Sponsor and Address
	Marketing Exclusivity 	Wyeth Pharmaceuticals, Inc.
	1/1/9999	P. O. Box 8299
	Philadelphia PA  19101-8299
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Antihemophilic factor (recombinant)	Treatment and prophylaxis of bleeding in patients with hemophilia A (not 
	von Willebrand's disease)
	Trade Name:
	Kogenate	Orphan Designation:
	Prophylaxis and treatment of bleeding in individuals with hemophilia A or 
	for prophylaxis when surgery is required in individuals with hemophilia A.
	Designation 
	9/25/1989	Sponsor and Address
	Marketing Exclusivity 	Bayer Corporation
	2/25/1993	1884 Miles Avenue
	Elkhart IN  46515 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antihemophilic factor/von Willebrand factor complex 	(1) In adult patients for treatment and prevention of bleeding in hemophilia
	(human), dried, pasteurized	 A (classic hemophilia) and (2) in adult and pediatric patients for treatment 
	of spontaneous and trauma-induced bleeding episodes in severe von 
	Trade Name:	Willebrand disease, and in mild and moderate von Willebrand disease 
	where use of desmopressin is known or suspected to be inadequate.
	Humate-P	Orphan Designation:
	Treatment of patients with von Willebrand's disease 
	Designation 
	10/16/1992	Sponsor and Address
	Marketing Exclusivity 	Aventis Behring L.L.C.
	4/1/1999	1020 First Avenue
	PO Box 61501
	King Of Prussia PA  19406-0901
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	anti-interferon-gamma Fab from goats
	Trade Name:
	Orphan Designation:
	For the treatment of immunologic corneal allograft rejection
	Designation 
	11/18/2003	Sponsor and Address
	Marketing Exclusivity 	Advanced Biotherapy, Inc.
	6355 Topanga Canyon Blvd.
	Suite 510
	Woodland Hills CA  91367 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antimelanoma Antibody XMMME-001-DTPA 111 
	Indium
	Trade Name:
	Antimelanoma Antibody XMMME-001-DTPA 111 	Orphan Designation:
	Indium
	Diagnostic use in imaging systemic and nodal melanoma metastasis.
	Designation 
	11/14/1984	Sponsor and Address
	Marketing Exclusivity 	Xoma Corporation
	2910 Seventh Street
	Berkeley CA  94710 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antimelanoma Antibody XMMME-001-RTA
	Trade Name:
	Antimelanoma Antibody XMMME-001-RTA	Orphan Designation:
	Treatment of stage III melanoma not amenable to surgical resection.
	Designation 
	11/14/1984	Sponsor and Address
	Marketing Exclusivity 	Xoma Corporation
	2910 Seventh Street
	Berkeley CA  94710 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Antipyrine Test
	Trade Name:
	Orphan Designation:
	For use as an index of hepatic drug-metabolizing capacity.
	Designation 
	2/21/1985	Sponsor and Address
	Marketing Exclusivity 	Upsher-Smith Laboratories, Inc
	4905 23rd Avenue North
	Minneapolis MN  55447 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antisense 20-mer oligonucleotide complementary to 
	R2 component of ribonucleotide reductase mRNA
	Trade Name:
	Orphan Designation:
	Treatment of acute myeloid leukemia 
	Designation 
	4/15/2005	Sponsor and Address
	Marketing Exclusivity 	Lorus Therapeutics, Inc.
	2 Meridan Road
	M9W 4Z7    
	 
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	antisense 20-mer phosphorothioate oligonucleotide 
	[complementary to the coding region of R2 
	component of the human ribonucleotide reductase 
	Trade Name:
	GTI-2040	Orphan Designation:
	Treatment for renal cell carcinoma
	Designation 
	3/12/2003	Sponsor and Address
	Marketing Exclusivity 	Lorus Therapeutics, Inc
	2 Meridan Road
	M9W427 
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antisense inhibitor of apoB-100
	Trade Name:
	Orphan Designation:
	Treatment of homozygous familial hypercholesterolemia
	Designation 
	5/23/2006	Sponsor and Address
	Marketing Exclusivity 	Isis Pharmaceuticals, Inc.
	1896 Rutherford ?Road
	Carlbad CA  92008 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anti-tap-72 immunotoxin
	Trade Name:
	Xomazyme-791	Orphan Designation:
	Treatment of metastatic colorectal adenocarcinoma.
	Designation 
	3/6/1987	Sponsor and Address
	Marketing Exclusivity 	Xoma Corporation
	2910 Seventh Street
	Berkeley CA  94710 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Anti-tenascin 81C6 monoclonal antibody labeled w/ I
	 131
	Trade Name:
	Neuradiab	Orphan Designation:
	Treatment of primary malignant brain tumors
	Designation 
	10/4/2005	Sponsor and Address
	Marketing Exclusivity 	Bradmer Pharmaceuticals, Inc.
	9900 Corporate Campus Drive
	Suite 3000
	Louisville KY  40223 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antithrombin III (human)
	Trade Name:
	ATnativ	Orphan Designation:
	For the treatment of patients with hereditary antithrombin III deficiency in 
	connection with surgical or obstetrical procedures or when they suffer from 
	Designation 	thromboembolism.
	2/8/1985	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn AB
	12/13/1989	Lindhagensgatan 133
	SE-112 87 
	    
	SWEDEN
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antithrombin III (human)
	Trade Name:
	Thrombate III	Orphan Designation:
	For replacement therapy in congenital deficiency of AT-III for prevention 
	and treatment of thrombosis and pulmonary emboli.
	Designation 
	11/26/1984	Sponsor and Address
	Marketing Exclusivity 	Bayer Corporation
	12/30/1991	Pharmaceutical Division, Biological Products
	400 Morgan Lane
	New Haven CT  06516 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antithrombin III (human) concentrate IV
	Trade Name:
	Kybernin P	Orphan Designation:
	For prophylaxis and treatment of thromboembolic episodes in patients with 
	genetic AT-III deficiency.
	Designation 
	7/2/1985	Sponsor and Address
	Marketing Exclusivity 	CSL Behring
	1020 First Ave.
	PO Box 61501
	King of Prussia PA  19406-0901
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antithrombin III human
	Trade Name:
	Antithrombin III human	Orphan Designation:
	Preventing or arresting episodes of thrombosis in patients with congenital 
	AT-III deficiency and/or to prevent the occurrence of thrombosis in patients 
	Designation 	with AT-III deficiency who have undergone trauma or who are about to 
	1/2/1986	undergo surgery or parturition.
	Sponsor and Address
	Marketing Exclusivity 	American National Red Cross
	9312 Old Georgetown Road
	Bethesda MD  20814 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Anti-thymocyte Globulin (Rabbitt)
	Trade Name:
	Thymoglobulin	Orphan Designation:
	Treatment of myelodysplastic syndrome (MDS)
	Designation 
	9/6/2000	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	500 Kendall Street
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anti-thymocyte serum
	Trade Name:
	Nashville Rabbit Anti-thymocyte Serum	Orphan Designation:
	Treatment of allograft rejection, including solid organ (kidney, liver, heart, 
	lung, and pancreas) and bone marrow transplantation.
	Designation 
	6/2/1993	Sponsor and Address
	Marketing Exclusivity 	Applied Medical Research
	1600 Hayes Street
	Nashville TN  37203 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antivenin crotaline (pit-viper) equine immune F(ab)2)
	Trade Name:
	Antivipmyn	Orphan Designation:
	Treatment of envenomation by Crotaline snakes
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	Rare Disease Therapeutics, Inc.
	1101 Kermit Drive,
	Suite 608
	Nashville TN  37217 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antivenin, crotalidae polyvalent immune Fab (ovine)	Carol Clark-Evans direct line (615) 963-4510
	Trade Name:
	CroFab	Orphan Designation:
	Treatment of envenomations inflicted by North American crotalid snakes.
	Designation 
	1/12/1994	Sponsor and Address
	Marketing Exclusivity 	Protherics, Inc.
	10/2/2000	1207 17th Ave. S., Suite 103
	Nashville TN  37212 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antivenom (crotalidae) purified (avian)
	Trade Name:
	Orphan Designation:
	Treatment of envenomation by poisonous snakes belonging to the 
	Crotalidae family.
	Designation 
	2/12/1991	Sponsor and Address
	Marketing Exclusivity 	Ophidian Pharmaceuticals, Inc.
	5445 East Cheryl Parkway
	Madison WI  53711 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Anti-von Willebrand Aptamer
	Trade Name:
	Orphan Designation:
	Treatment of thrombotic thrombocytopenic purpura
	Designation 
	4/9/2008	Sponsor and Address
	Marketing Exclusivity 	Archemix Corporation
	300 Third Street
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	AP1903
	Trade Name:
	Orphan Designation:
	Treatment of acute graft-versus-host disease in patients undergoing bone 
	marrow transplantation. 
	Designation 
	11/24/1999	Sponsor and Address
	Marketing Exclusivity 	Ariad Pharmaceuticals, Inc.
	26 Landsdowne St.
	Cambridge MA  02139-4234
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	APL 400-020 V-Beta DNA vaccine
	Trade Name:
	Orphan Designation:
	Treatment of cutaneous T cell lymphoma.
	Designation 
	3/8/1995	Sponsor and Address
	Marketing Exclusivity 	Wyeth-Lederle Vaccines and Pediatrics
	211 Bailey Rd.
	West Henrietta NY  14586-9728
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Apomorphine
	Trade Name:
	Orphan Designation:
	For use as rescue treatment for early morning motor dysfunction in late-
	stage Parkinson's disease.
	Designation 
	10/20/1997	Sponsor and Address
	Marketing Exclusivity 	Scherer DDS
	Frankland Road
	Swindon   SN5 8RU
	Wiltshire    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Apomorphine
	Trade Name:
	Orphan Designation:
	Treatment of the on-off fluctuations associated with late-stage Parkinson's 
	disease.
	Designation 
	7/17/1995	Sponsor and Address
	Marketing Exclusivity 	Pentech Pharmaceuticals, Inc.
	1110 Lake Cook Rd.
	Suite 257
	Buffalo Grove IL  60089 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Apomorphine HCl	For the acute, intermittent treatment of hypomobility, "off" episodes ("end-
	of-dose-wearing-off" and unpredictable :on/off" episodes) associated with 
	advanced Parkinson's disease
	Trade Name:
	Apokyn	Orphan Designation:
	Treatment of the on-off fluctuations associated with late-stage Parkinson's 
	disease.
	Designation 
	4/22/1993	Sponsor and Address
	Marketing Exclusivity 	Vernalis R & D Ltd
	4/20/2004	Oakdene Court
	Winnersh, Berkshire RG41 5UA
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Apomorphine hydrochloride
	Trade Name:
	Orphan Designation:
	For the treatment of patients in a vegetative state or minimally conscious 
	state for up to 12 months following a severe traumatic brain injury 
	Designation 	(traumatic or spontaneous)
	5/23/2006	Sponsor and Address
	Marketing Exclusivity 	NeuroHealing Pharmaceuticals, Inc.
	50 Undine Road
	Newton MA  02135 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aprotinin
	Trade Name:
	Trasylol	Orphan Designation:
	For prophylactic use to reduce perioperative blood loss and the 
	homologous blood transfusion requirement in patients undergoing 
	Designation 	cardiopulmonary bypass surgery in the course of repeat coronary artery 
	11/17/1993	bypass graft surgery, and in selected cases of primary coronary artery bypass
	 graft surgery where the risk of bleeding is especially high (impaired 
	hemostasis) or where transfusion is unavailable or unacceptable.
	Sponsor and Address
	Marketing Exclusivity 	Bayer Corporation
	12/29/1993	Pharmaceutical Division
	400 Morgan Lane
	West Haven CT  06516 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Arcitumomab
	Trade Name:
	99m Tc-labeled CEA-Scan	Orphan Designation:
	Diagnosis and localization of primary, residual, recurrent and metastatic 
	medullary thyroid carcinoma.
	Designation 
	5/10/1996	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Arginine butyrate
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell disease and beta thalassemia.
	Designation 
	5/25/1994	Sponsor and Address
	Marketing Exclusivity 	Vertex Pharmaceuticals Inc.
	130  Waverly Street
	Cambridge MA  02139-4242
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Arginine butyrate
	Trade Name:
	Orphan Designation:
	Treatment of beta-hemoglobinopathies and beta-thalassemia.
	Designation 
	4/7/1992	Sponsor and Address
	Marketing Exclusivity 	Perrine, Susan P., M.D.
	Boston University
	Cancer Research Center
	Boston MA  02118 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	arimoclomol
	Trade Name:
	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis
	Designation 
	3/29/2005	Sponsor and Address
	Marketing Exclusivity 	CytRx Corporation
	3030 Bunker Hill Street
	Suite 105
	San Diego CA  92109 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aripiprazole
	Trade Name:
	Abilify	Orphan Designation:
	Treatment of Tourette's syndrome 
	Designation 
	1/25/2006	Sponsor and Address
	Marketing Exclusivity 	Floyd R. Sallee, M.D., Ph.D.
	University of Cincinnati School of Medicine/
	P. O. Box 670669     231 Albert Sabin Way
	Cincinnati OH  45267-0559
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	arsenic
	Trade Name:
	Trisenox	Orphan Designation:
	Treatment of acute myelocytic leukemia subtypes M0, M1, M2, M4, M5, M6
	 and M7
	Designation 
	11/2/2001	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	41 Moores Road
	Frazer PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Arsenic trioxide
	Trade Name:
	Trisenox	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	3/4/2005	Sponsor and Address
	Marketing Exclusivity 	Cephalon Inc
	41 Moores Road
	P. O. Box 4011
	Frazer PA  19355 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	arsenic trioxide
	Trade Name:
	Trisenox	Orphan Designation:
	Treatment of chronic myeloid leukemia
	Designation 
	10/18/2001	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	41 Moores Road
	Frazer PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Arsenic trioxide	For induction of remission and consolidation in patients with acute 
	promyelocytic leukemia (APL) who are refractory to, or have relapsed from, 
	retinoid and anthracycline chemotherapy, and whose APL is characterized 
	Trade Name:	by the presence of the t(15;17) translocation of PML/RAR-alpha gene 
	Trisenox	Orphan Designation:
	Treatment of acute promyelocytic leukemia.
	Designation 
	3/3/1998	Sponsor and Address
	Marketing Exclusivity 	Cell Therapeutics, Inc.
	9/25/2000	201 Elliott Ave. West
	Suite 400
	Seattle WA  98119 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Arsenic trioxide
	Trade Name:
	Trisenox	Orphan Designation:
	Treatment of multiple myeloma.
	Designation 
	4/28/2000	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	41 Moores Road
	Frazer PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	arsenic trioxide
	Trade Name:
	Trisenox	Orphan Designation:
	Treatment of liver cancer
	Designation 
	6/13/2003	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	41 Moores Road
	Frazer PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Arsenic trioxide
	Trade Name:
	Trisenox	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	5/13/2003	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	41 Moores Road
	Frazer PA  19355 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	arsenic trioxide
	Trade Name:
	Trisenox	Orphan Designation:
	Treatment of myelodysplastic syndrome.
	Designation 
	7/17/2000	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	41 Moores Road
	P.O. Box 4011
	Frazer PA  19355 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	artemether/lumefantrine
	Trade Name:
	Coartem	Orphan Designation:
	For the treatment of infections due to Plasmodium falciparum or mixed 
	infections including P. falciparum.
	Designation 
	8/31/2007	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals
	Bldg 405/4051
	One Health Plaza
	East Hanover NJ  07936-1080
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Artesunate
	Trade Name:
	Orphan Designation:
	Immediate treatment of malaria
	Designation 
	3/28/2006	Sponsor and Address
	Marketing Exclusivity 	US Army Medical Materiel Development Activity
	Office of the Surgeon General
	622 Neiman Street
	Ft. Detrick MD  21702-9240
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Artesunate
	Trade Name:
	Orphan Designation:
	Treatment of malaria.
	Designation 
	7/19/1999	Sponsor and Address
	Marketing Exclusivity 	World Health Organization
	Special Programme for Research and Training in Tro
	Via Appia , Geneva 27
	    
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	arylsulfatase A (rhARSA)
	Trade Name:
	Orphan Designation:
	Treatment of metachromatic leukodystrophy.
	Designation 
	2/27/2008	Sponsor and Address
	Marketing Exclusivity 	Shire Human Genetic Therapies, Inc.
	700 Main Street
	Cambridge MA  02139 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	As-101
	Trade Name:
	Orphan Designation:
	Treatment of acquired immunodeficiency syndrome.
	Designation 
	11/9/1987	Sponsor and Address
	Marketing Exclusivity 	NPDC-AS101, Inc.
	783 Jersey Avenue
	New Brunswick NJ  08901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ascorbic acid
	Trade Name:
	Ascor L 500	Orphan Designation:
	Treatment of scurvy 
	Designation 
	8/31/2007	Sponsor and Address
	Marketing Exclusivity 	McGuff Pharmaceuticals Inc.
	2921 W. McArthur Blvd.
	Santa Ana CA  92704-6929
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Atomoxetine hydrochloride
	Trade Name:
	STRATTERA	Orphan Designation:
	Treatment of Tourette's Syndrome
	Designation 
	8/26/2003	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly & Company
	Lilly Corporate Center
	Indianapolis IN  46285 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Atovaquone	Prevention of PCP in patients who are intolerant to trimethoprim-
	sulfamethoxazole.
	Trade Name:
	Mepron	Orphan Designation:
	Prevention of Pneumocystis carinii pneumonia (PCP) in high-risk, HIV-
	infected patients defined by a history of one or more episodes of PCP 
	Designation 	and/or a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or
	8/14/1991	Sponsor and Address	 equal to 200/mm3.
	Marketing Exclusivity 	Glaxo Wellcome Research and Development
	1/5/1999	5 Moore Drive
	PO Box 13398
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Atovaquone	For the acute oral treatment of mild to moderate Pneumocystis carinii 
	pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.
	Trade Name:
	Mepron	Orphan Designation:
	Treatment of AIDS associated Pneumocystis Carinii Pneumonia.
	Designation 
	9/10/1990	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	11/25/1992	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Atovaquone
	Trade Name:
	Mepron	Orphan Designation:
	Primary prophylaxis of HIV-infected persons at high risk for developing 
	Toxoplasma gondii encephalitis.
	Designation 
	3/16/1993	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline,  Inc.
	5 Moore Drive
	PO Box 13398
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Atovaquone
	Trade Name:
	Mepron	Orphan Designation:
	Treatment and suppression of Toxoplasma gondii encephalitis.
	Designation 
	3/16/1993	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline,  Inc.
	5 Moore Drive
	PO Box 13398
	Research Triangle Park NC  27709-3398
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Attenuated autologous cancer cells and granulocyte 
	macrophage colony stimulating factor in 
	combination with activated autologous blood derived
	Trade Name:
	Orphan Designation:
	Treatment of primary central nervous system malignancies
	Designation 
	4/27/2007	Sponsor and Address
	Marketing Exclusivity 	TVAX Biomedical, LLC
	8060 Reeder Street
	Lenexa KS  66214-1554
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	augmerosen
	Trade Name:
	Genasense	Orphan Designation:
	Treatment of acute myelocytic leukemia
	Designation 
	8/28/2001	Sponsor and Address
	Marketing Exclusivity 	Genta Inc.
	Two Connell Drive
	Berkeley Heights NJ  07922 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	augmerosen
	Trade Name:
	Genasense	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	8/28/2001	Sponsor and Address
	Marketing Exclusivity 	Genta, Inc.
	Two Connell Drive
	Berkeley Heights NJ  07922 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	augmerosen
	Trade Name:
	Genasense	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	8/28/2001	Sponsor and Address
	Marketing Exclusivity 	Genta, Inc,
	Two Connell Drive
	Berkeley Heights NJ  07922 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	autologous antigen presenting cells pulsed with 
	autologous tumor Ig idiotype
	Trade Name:
	Mylovenge	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	4/18/2002	Sponsor and Address
	Marketing Exclusivity 	Dendreon Corporation
	3005 First Avenue
	Seattle WA  98121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Autologous cultured endothelial cells on a donor 
	human corneal disk
	Trade Name:
	Orphan Designation:
	Treatment of Fuch's dystrophy, pseudophakic bullous keratopathy, and 
	bullous keratopathy
	Designation 
	6/1/2007	Sponsor and Address
	Marketing Exclusivity 	Cellular Bioengineering, Inc.
	1946 Young Street
	Honolulu HI  96826 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Autologous dendritic cells pulsed with autologous 
	antigens from primay malignant brain tumor cells
	Trade Name:
	DCVax-Brain	Orphan Designation:
	Treatment of primary brain malignant cancer
	Designation 
	11/29/2002	Sponsor and Address
	Marketing Exclusivity 	Northwest Biotherapeutics, Inc.
	22322 20th Avenue SE
	Suite 150
	Bothell WA  98021 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Autologous DNP-conjugated tumor vaccine
	Trade Name:
	M-Vax	Orphan Designation:
	For adjuvant therapy in melanoma patients with surgically resectable lymph
	 node metastasis (Stage III and limited Stage IV disease).
	Designation 
	2/23/1999	Sponsor and Address
	Marketing Exclusivity 	Avax Technologies, Inc.
	9200 Indian Creek Parkway
	Building 9, Suite 200
	Overland Park KS  66210 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Autologous incubated macrophage
	Trade Name:
	Orphan Designation:
	Therapy to improve the motor and sensory neurological outcome in acute 
	cases of spinal cord injury
	Designation 
	9/3/2004	Sponsor and Address
	Marketing Exclusivity 	Proneuron Biotechnologies, Inc.
	2029 Century Park East
	Sixth Floor
	Los Angeles CA  90067 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Autologous olfactory neural progenitors
	Trade Name:
	RhinoCytes	Orphan Designation:
	Treatment of spinal cord injury patients with ASIA Impairment grades A, B, 
	or C
	Designation 
	2/1/2008	Sponsor and Address
	Marketing Exclusivity 	RhinoCyte, Inc.
	201 E. Jefferson Street
	Louisville KY  40202-1246
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Autologous or allogeneic limbal epithelial stem cells
	 expanded ex vivo on human amniotic membrane
	Trade Name:
	Orphan Designation:
	Treatment of ocular surface diseases that are characterized by total limbal 
	stem cell deficiency
	Designation 
	7/14/2005	Sponsor and Address
	Marketing Exclusivity 	TissueTech, Inc.
	7000 SW 97th Avenue
	Miami FL  33173 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	autologous tumor-derived gp96 heat shock protein-
	peptide complex
	Trade Name:
	Oncophage	Orphan Designation:
	Treatment of renal cell carcinoma
	Designation 
	5/10/2002	Sponsor and Address
	Marketing Exclusivity 	Antigenics, Inc.
	3 Forbes Rd. 
	Lexington  MA  02421 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	autologous tumor-derived gp96 heat shock protein-
	peptide complex
	Trade Name:
	Oncophage	Orphan Designation:
	Treatment of metastatic melanoma
	Designation 
	7/11/2002	Sponsor and Address
	Marketing Exclusivity 	Antigenics, Inc.
	3 Forbes Rd. 
	l MA  02421 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Autolymphocyte therapy
	Trade Name:
	Orphan Designation:
	Treatment of renal cell carcinoma.
	Designation 
	7/12/1994	Sponsor and Address
	Marketing Exclusivity 	Cytogen Corporation
	600 College Road East
	CN 5308
	Princeton NJ  08540-5308
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	aviptadil
	Trade Name:
	Orphan Designation:
	Treatment of pulmonary arterial hypertension 
	Designation 
	2/22/2005	Sponsor and Address
	Marketing Exclusivity 	Biogen Idec MA, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	axitinib
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	5/31/2007	Sponsor and Address
	Marketing Exclusivity 	Pfizer, Inc.
	La Jolla Laboratories
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	azacitidine	Treatment of patients with the following myelodysplastic syndrome 
	subtypes:  refractory anemia or refractory anemia with ringed sideroblasts (if 
	accompanied by neutropenia or thrombocytopenia and requiring 
	Trade Name:	transfusions), refractory anemia with excess blasts, refractory anemia with 
	excess blasts in transformation, and chronic myelomonocytic leukemia
	Vidaza	Orphan Designation:
	Treatament of myelodysplastic syndromes
	Designation 
	12/3/2001	Sponsor and Address
	Marketing Exclusivity 	Pharmion Corporation
	5/19/2004	2525 28th Street
	Boulder CO  80301 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Azathioprine
	Trade Name:
	Imuran	Orphan Designation:
	Treatment of oral manifestations of graft-versus-host disease.
	Designation 
	9/14/1999	Sponsor and Address
	Marketing Exclusivity 	Oral Solutions, Inc.
	787 Seventh Ave., 48th Floor
	New York NY  10019 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	aztreonam
	Trade Name:
	Orphan Designation:
	Inhalation therapy for control of gram-negative bacteria in the respiratory 
	tract of patients with cystic fibrosis
	Designation 
	3/12/2002	Sponsor and Address
	Marketing Exclusivity 	Gilead Sciences (formerly Corus Pharma)
	2025 First Ave.
	Suite 800
	Seattle WA  98121 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bacillus Calmette-Guerin vaccine
	Trade Name:
	Orphan Designation:
	Treatment of stage IIb through IV metastatic melanoma
	Designation 
	8/9/2006	Sponsor and Address
	Marketing Exclusivity 	OncoVac Corporation
	P. O. Box 970
	Pacific Palisades CA  90272 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bacitracin
	Trade Name:
	Altracin	Orphan Designation:
	Treatment of antibiotic-associated pseudomembranous enterocolitis caused
	 by toxins A and B elaborated by Clostridium difficile.
	Designation 
	3/13/1984	Sponsor and Address
	Marketing Exclusivity 	A. L. Laboratories, Inc.
	One Executive Drive
	P.O. Box 1399
	Fort Lee NJ  07024 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Baclofen	Management of severe spasticity of spinal cord origin in patients who are 
	unresponsive to oral baclofen therapy or experience intolerable CNS side 
	effects at effective doses.
	Trade Name:
	Lioresal Intrathecal	Orphan Designation:
	Treatment of intractable spasticity caused by spinal cord injury, multiple 
	sclerosis, and other spinal diseases (including spinal ischemia, spinal tumor,
	Designation 	 transverse myelitis, cervical spondylosis, and degenerative myelopathy).
	11/10/1987	Sponsor and Address
	Marketing Exclusivity 	Medtronic, Inc.
	6/25/1992	800 53rd Avenue N.E.
	Minneapolis MN  55432 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Baclofen
	Trade Name:
	Orphan Designation:
	Treatment of intractable spasticity due to multiple sclerosis or spinal cord 
	injury.
	Designation 
	12/16/1991	Sponsor and Address
	Marketing Exclusivity 	Infusaid, Inc.
	1400 Providence Highway
	Norwood MA  02062 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Baclofen
	Trade Name:
	Lioresal Intrathecal	Orphan Designation:
	Treatment of spasticity associated with cerebral palsy.
	Designation 
	9/26/1994	Sponsor and Address
	Marketing Exclusivity 	Medtronic, Inc.
	800 53rd Avenue N.E.
	P.O. 1250
	Minneapolis MN  55440-9087
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	baclofen
	Trade Name:
	Orphan Designation:
	Treatment of dystonia
	Designation 
	12/2/2003	Sponsor and Address
	Marketing Exclusivity 	Medtronic Neurological
	710 Medtronic Parkway NE
	Minneapolis MN  55432-5604
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Balsalazide disodium	Treatment of mildly to moderately active ulcerative colitis in patients 5 
	years of age and older.  Safety and Effectiveness of Colazal beyond 8 
	weeks in children (ages 5-17) and 12 weeks in adults have not been 
	Trade Name:	established.
	Colazal	Orphan Designation:
	Treatment of pediatric patients with ulcerative colitis
	Designation 
	8/12/2005	Sponsor and Address
	Marketing Exclusivity 	Salix Pharmaceuticals, Inc.
	12/20/2006	1700 Perimeter Park Drive
	Morrisville NC  27560 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Basiliximab	Prophylaxis of acute organ rejection in patients receiving renal 
	transplantation when used as part of an immunosuppressive regimen that 
	includes cyclosporine and corticosteroids.
	Trade Name:
	Simulect	Orphan Designation:
	Prophylaxis of solid organ rejection.
	Designation 
	12/12/1997	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	5/12/1998	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	beclomethasone 17,21-dipropionate
	Trade Name:
	Bec	Orphan Designation:
	Prevention of gastrointestinal graft-versus-host disease
	Designation 
	8/28/2001	Sponsor and Address
	Marketing Exclusivity 	Enteron Pharmaceuticals, Inc./DOR BioPharma, Inc.
	A Subsidiary of DOR BioPharma, Inc.
	850 Bear Tavern Road
	Ewing NJ  08628 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	beclomethasone 17,21-diproprionate
	Trade Name:
	Orphan Designation:
	Treatment of pediatric patients with Crohn disease.
	Designation 
	12/18/2007	Sponsor and Address
	Marketing Exclusivity 	DOR BioPharma, Inc.
	850 Bear Tavern Road
	Suite 201
	Ewing NJ  08628 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Beclomethasone dipropionate
	Trade Name:
	Orphan Designation:
	For oral administration in the treatment of intestinal graft-versus-host 
	disease.  
	Designation 
	3/27/1998	Sponsor and Address
	Marketing Exclusivity 	Enteron Pharmaceuticals, Inc./DOR BioPharma, Inc.
	A Subsidiary of DOR BioPharma, Inc.
	850 Bear Tavern Road
	Ewing NJ  08628 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	belatacept
	Trade Name:
	Orphan Designation:
	Prophylaxis of organ rejection in renal allograft recipients
	Designation 
	2/20/2008	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Company
	P. O. Box 4000
	Princeton NJ  08543-4000
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bendamustine hydrochloride	Treatment of patients with chronic lymphocytic leukemia
	Trade Name:
	Treanda	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	8/17/2007	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	3/20/2008	41 Moores Road
	Frazer PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Benzoate and phenylacetate
	Trade Name:
	Ucephan	Orphan Designation:
	For adjunctive therapy in the prevention and treatment of 
	hyperammonemia in patients with urea cycle enzymopathy due to 
	Designation 	carbamylphosphate synthetase, ornithine, transcarbamylase, or 
	1/21/1986	Sponsor and Address	argininosuccinate synthetase deficiency.
	Marketing Exclusivity 	Immunex
	12/23/1987		2525 McGaw Avenue
	12/23/1987	Immunex
	P.O. Box 19791
	Irvine CA  92623 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	benzoate/phenylacetate	Adjunctive therapy in the treatment of acute hyperammonemia and 
	associated encephalopathy in patients with deficiencies in enzymes of the 
	urea cycle.
	Trade Name:	
	Ammonul	Orphan Designation:
	Treatment of acute hyperammonemia and associated  encephalopathy in 
	patients with deficiencies in enzymes of the urea cycle.
	Designation 
	11/22/1993	Sponsor and Address
	Marketing Exclusivity 	Medicis Pharmaceutical Corp.
	2/17/2005	8125 N. Hayden Road
	Scottsdale AZ  85258 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Benzophenone-3, octylmethoxycinnamate, 
	avobenzone, titanium dioxide, zinc oxide
	Trade Name:
	Total Block VL SPF 75	Orphan Designation:
	For the prevention of visible light induced skin photosensitivity as a result of
	 porfimer sodium photodynamic therapy
	Designation 
	8/13/2001	Sponsor and Address
	Marketing Exclusivity 	Fallien Cosmeceuticals Ltd.
	677 W. Dekalb Pike
	King of Prussia PA  19406 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Benzydamine hydrochloride
	Trade Name:
	Tantum	Orphan Designation:
	Prophylactic treatment of oral mucositis resulting from radiation therapy for 
	head and neck cancer.
	Designation 
	5/18/1998	Sponsor and Address
	Marketing Exclusivity 	Angelini Pharmaceuticals, Inc.
	70 Grand Avenue
	River Edge NJ  07661 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Benzylpenicillin, benzylpenicilloic, benzylpenilloic 
	acid
	Trade Name:
	Pre-Pen/MDM	Orphan Designation:
	Assessing the risk of administrating penicillin when it is the preferred drug of
	 choice in adult patients who have previously received penicillin and have 
	Designation 	a history of clinical sensitivity.
	9/29/1987	Sponsor and Address
	Marketing Exclusivity 	AllerQuest LLC
	836 Farmington Avenue
	Suite 207
	West Hanford CT  06119-1551
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Beractant
	Trade Name:
	Survanta Intratracheal Suspension	Orphan Designation:
	Treatment of full-term newborn infants with respiratory failure caused by 
	meconium aspiration syndrome, persistent pulmonary hypertension of the 
	Designation 	newborn, or pneumonia and sepsis.
	12/20/1993	Sponsor and Address
	Marketing Exclusivity 	Ross Laboratories
	625 Cleveland Avenue
	Columbus OH  43215 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Beractant	Prevention of RDS (hyaline membrane disease) in premature infants less 
	than 1250 grams birthweight or with evidence of surfactant deficiency.
	Trade Name:
	Survanta intratracheal suspension	Orphan Designation:
	Prevention of neonatal respiratory distress syndrome.
	Designation 
	2/5/1986	Sponsor and Address
	Marketing Exclusivity 	Ross Laboratories
	7/1/1991	625 Cleveland Avenue
	Columbus OH  43215 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Beractant	Treatment of ("rescue") of premature infants with RDS confirmed by x-ray 
	and requiring mechanical ventilation.
	Trade Name:
	Survanta intratracheal suspension	Orphan Designation:
	Treatment of neonatal respiratory distress syndrome.
	Designation 
	2/5/1986	Sponsor and Address
	Marketing Exclusivity 	Ross Laboratories
	7/1/1991	625 Cleveland Avenue
	Columbus OH  43215 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Beraprost
	Trade Name:
	Orphan Designation:
	Treatment of pulmonary arterial hypertension associated with any New York
	 Heart Association classification (Class I, II, III, or IV).  
	Designation 
	4/29/1999	Sponsor and Address
	Marketing Exclusivity 	United Therapeutics Corporation
	68 T.W. Alexander Drive, PO Box 14186
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Beta alethine
	Trade Name:
	Betathine	Orphan Designation:
	Treatment of metastatic melanoma.
	Designation 
	3/24/1997	Sponsor and Address
	Marketing Exclusivity 	Dovetail Technologies, Inc.
	Bldg. 337, Paint Branch Drive
	College Park MD  20742 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Beta alethine
	Trade Name:
	Betathine	Orphan Designation:
	Treatment of multiple myeloma.
	Designation 
	3/24/1997	Sponsor and Address
	Marketing Exclusivity 	Dovetail Technologies, Inc.
	Bldg. 337, Paint Branch Drive
	College Park MD  20742 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Betahistine dihydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of obesity associated with Prader Willi syndrome
	Designation 
	11/8/2007	Sponsor and Address
	Marketing Exclusivity 	Floyd R. Sallee, M.D., Ph.D.
	University of Cincinnati School of Medicine
	ML 0559
	Cincinnati OH  45267-0559
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Betaine	Treatment of homocystinuria to decrease elevated homocysteine blood 
	levels.
	Trade Name:
	Cystadane	Orphan Designation:
	Treatment of homocystinuria.
	Designation 
	5/16/1994	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals
	10/25/1996	3180 Porter Drive
	Palo Alto  CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bethanidine sulfate
	Trade Name:
	Orphan Designation:
	Prevention of recurrence of primary ventricular fibrillation.
	Designation 
	11/24/1989	Sponsor and Address
	Marketing Exclusivity 	Medco Research, Inc.
	8455 Beverly Blvd.
	Suite 308
	Los Angeles CA  90048 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bethanidine sulfate
	Trade Name:
	Orphan Designation:
	Treatment of primary ventricular fibrillation.
	Designation 
	9/20/1988	Sponsor and Address
	Marketing Exclusivity 	Medco Research, Inc.
	8455 Beverly Blvd.
	Suite 308
	Los Angeles CA  90048 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Betulinic acid
	Trade Name:
	Orphan Designation:
	Topical treatment of metastatic melanoma
	Designation 
	8/9/2007	Sponsor and Address
	Marketing Exclusivity 	Advanced Life Sciences, Inc. (ALS)
	1440 Davey Road
	Woodridge IL  60517 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Bevacizamub
	Trade Name:
	Avastin	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	5/26/2006	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1 DNA Way
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bevacizumab
	Trade Name:
	Avastin	Orphan Designation:
	Therapeutic treatment of patients with ovarian cancer
	Designation 
	2/9/2006	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1 DNA Way
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bevacizumab
	Trade Name:
	Avastin	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	10/20/2004	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1 DNA Way, MS #242 
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bevacizumab
	Trade Name:
	Avastin	Orphan Designation:
	Treatment of renal cell carcinoma
	Designation 
	11/6/2003	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1 DNA Way
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bexarotene	Treatment of cutaneous manifestations of cutaneous T-cell lymphoma in 
	patients who are refractory to at least one prior systemic therapy.  
	Trade Name:
	Targretin	Orphan Designation:
	Treatment of cutaneous T-cell lymphoma.  
	Designation 
	6/18/1999	Sponsor and Address
	Marketing Exclusivity 	Eisai Medical Research, Inc.
	12/29/1999	55 Challenger Road
	Ridgefield Park NJ  07660 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	bifidobacterium infantis 35624
	Trade Name:
	Orphan Designation:
	Treatment of pediatric ulcerative colitis.
	Designation 
	3/24/2008	Sponsor and Address
	Marketing Exclusivity 	Alimentary Health Limited
	Cork Airport Business Park, Building 2800
	Cork
	    
	IRELAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	bifidobacterium longum infantis 35624
	Trade Name:
	Orphan Designation:
	Treatment of pediatric Crohn's disease
	Designation 
	1/16/2003	Sponsor and Address
	Marketing Exclusivity 	Alimentary Health Limited
	Guardwell, Kinsale
	County Cork    
	 
	IRELAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bindarit
	Trade Name:
	Orphan Designation:
	Treatment of lupus nephritis.
	Designation 
	2/3/1998	Sponsor and Address
	Marketing Exclusivity 	Angelini Pharmaceuticals, Inc.
	70 Grand Avenue
	Suite 109
	River Edge NJ  07661 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bioartificial liver system utilizing xenogenic 
	hepatocytes in a hollow fiber bioreactor cartridge 
	Trade Name:
	Orphan Designation:
	Treatment of patients with acute liver failure presenting with 
	encephalopathy deteriorating beyond Parson's grade 2
	Designation 
	2/11/2002	Sponsor and Address
	Marketing Exclusivity 	Excorp Medical, Inc.
	Suite 235
	7200 Hudson Blvd.
	Oakdale MN  55128 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	biocarbonate infusate	Use as a replacement solution in Continuous Renal Replacement Therapy 
	(CRRT) to replace water and to correct electrolytes and acid-base 
	imbalances in adults and children
	Trade Name:
	Normocarb HF	Orphan Designation:
	Use in the management of patients undergoing continuous renal 
	replacement therapy with hemofiltration
	Designation 
	8/9/2005	Sponsor and Address
	Marketing Exclusivity 	Dialysis Solutions, Inc.
	7/26/2006	14 Emmett Place
	Whitby, Ontario L1R 2B4
	    
	CANADA
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Bio-engineered oral mucosal tissue
	Trade Name:
	Orphan Designation:
	For use as a graft for restoring a cornea-like epithelial phenotype to 
	substitute for the normal corneal epithelium that is lost in patients due to 
	Designation 	total limbal stem cell deficiency
	4/27/2006	Sponsor and Address
	Marketing Exclusivity 	TissueTech, Inc.
	7000 SW 97th Avenue
	Miami FL  33173 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bis(4-fluorophenyl)phenylacetamide
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell disease.
	Designation 
	3/2/2000	Sponsor and Address
	Marketing Exclusivity 	ICAgen Inc.
	Ion Channel Advances
	PO Box 14487
	Durham NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bispecific molecule with two linked murine single-
	chain Fv regions against CD3 & CD19
	Trade Name:
	Orphan Designation:
	Treatment of prolymphocytic leukemia
	Designation 
	5/16/2008	Sponsor and Address
	Marketing Exclusivity 	MedImmune, LLC
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bispecific molecule with two linked murine single-
	chain Fv regions against CD3 & CD19
	Trade Name:
	Orphan Designation:
	Treatment for hairy cell leukemia.
	Designation 
	5/16/2008	Sponsor and Address
	Marketing Exclusivity 	MedImmune, LLC
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bispecific molecule with two linked murine single-
	chain Fv regions against CD3 & CD19
	Trade Name:
	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	5/16/2008	Sponsor and Address
	Marketing Exclusivity 	MedImmune, LLC
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Bispecific molecule with two linked murine single-
	chain Fv regions against CD3 & CD19
	Trade Name:
	Orphan Designation:
	Treatment of acute lymphocytic leukemia
	Designation 
	5/16/2008	Sponsor and Address
	Marketing Exclusivity 	MedImmune, LLC
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bispecific molecule with two linked murine single-
	chain Fv regions directed against CD3 & CD19
	Trade Name:
	Orphan Designation:
	Treatment of indolent B-cell lymphoma, excluding CLL and NHL with CNS 
	involvement
	Designation 
	2/6/2006	Sponsor and Address
	Marketing Exclusivity 	MedImmune, LLC
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	bivalirudin
	Trade Name:
	Angiomax	Orphan Designation:
	For use as an anticoagulant in patients with or at risk of heparin-induced 
	thrombocytopenia/heparin-induced thrombocytopenia thrombosis syndrome
	Designation 
	11/2/2005	Sponsor and Address
	Marketing Exclusivity 	The Medicines Company
	8 Campus Drive
	Parsippany NJ  07054 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bleomycin
	Trade Name:
	Blenoxane	Orphan Designation:
	Treatment of pancreatic cancer.
	Designation 
	2/9/1999	Sponsor and Address
	Marketing Exclusivity 	Genetronics, Inc.
	11199 Sorrento Valley Rd.
	San Diego CA  92121-1334
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bleomycin sulfate	Treatment of malignant pleural effusion.
	Trade Name:
	Blenoxane	Orphan Designation:
	Treatment of malignant pleural effusion.
	Designation 
	9/17/1993	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	2/20/1996	P.O. Box 4000
	Princeton NJ  08543 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	BMY-45622
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	10/15/1990	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb
	5 Research Parkway
	Wallingford CT  06492 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bortezomib	Treatment of multiple myeloma patients who have received at least  one 
	prior therapy
	Trade Name:
	Velcade	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	1/15/2003	Sponsor and Address
	Marketing Exclusivity 	Millennium Pharmaceuticals, Inc.
	3/25/2005	40 Landsdowne Street
	Canbridge  MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bosentan	Treatment of pulmonary arterial hypertension.
	Trade Name:
	Tracleer	Orphan Designation:
	Treatment of pulmonary arterial hypertension.
	Designation 
	10/6/2000	Sponsor and Address
	Marketing Exclusivity 	Actelion Life Sciences Ltd.
	11/20/2001	1840 Gateway Dr.
	2nd Floor
	San Mateo CA  94404 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type A
	Trade Name:
	Dysport	Orphan Designation:
	Treatment of dynamic muscle contractures in pediatric cerebral palsy 
	patients.
	Designation 
	10/20/1999	Sponsor and Address
	Marketing Exclusivity 	Ipsen Limited
	1 Bath Rd., Maidenhead
	Berkshire SL6 4UH    
	 
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type A
	Trade Name:
	Dysport	Orphan Designation:
	Treatment of spasmodic torticollis (cervical dystonia).
	Designation 
	8/12/1998	Sponsor and Address
	Marketing Exclusivity 	Ipsen Limited
	1 Bath Road
	Maidenhead
	Berkshire, SL6 4UH     
	UNITED KINGDOM
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Botulinum toxin type A
	Trade Name:
	Dysport	Orphan Designation:
	Treatment of essential blepharospasm.
	Designation 
	3/23/1989	Sponsor and Address
	Marketing Exclusivity 	Porton International, Inc.
	1155 15th Street, N.W., #315
	Washington DC  20005 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type A
	Trade Name:
	Botox	Orphan Designation:
	Treatment of dynamic muscle contracture in pediatric cerebral palsy 
	patients.
	Designation 
	12/6/1991	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92623-9534
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type A
	Trade Name:
	Orphan Designation:
	Treatment of synkinetic closure of the eyelid associated with VII cranial 
	nerve aberrant regeneration.
	Designation 
	9/15/1992	Sponsor and Address
	Marketing Exclusivity 	Botulinum Toxin Research Associates, Inc.
	1261 Furnace Brook Parkway
	Quincy MA  02169 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type A	Treatment of cervical dystonia in adults to decrease the severity of 
	abnormal head position and neck pain associated with cervical dystonia.
	Trade Name:
	Botox	Orphan Designation:
	Treatment of cervical dystonia.
	Designation 
	8/20/1986	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	12/21/2000	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92623-9534
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type A
	Trade Name:
	Botox	Orphan Designation:
	Treatment of strabismus associated with dystonia in adults (patients 12 
	years of age and above).
	Designation 
	3/22/1984	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	12/29/1989	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92713 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Botulinum toxin type A
	Trade Name:
	Botox	Orphan Designation:
	Treatment of blepharospasm associated with dystonia in adults (patients 12 
	years of age and above).
	Designation 
	3/22/1984	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	12/29/1989	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92713 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type B	Treatment of patients  with cervical dystonia to reduce the severity of 
	abnormal head position and neck pain associated with cervical dystonia.
	Trade Name:
	Myobloc	Orphan Designation:
	Treatment of cervical dystonia.
	Designation 
	1/16/1992	Sponsor and Address
	Marketing Exclusivity 	Elan Pharmaceuticals, Inc.
	12/8/2000	800 Gateway Blvd.
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type F
	Trade Name:
	Orphan Designation:
	Treatment of spasmodic torticollis (cervical dystonia).
	Designation 
	10/24/1991	Sponsor and Address
	Marketing Exclusivity 	Ipsen Limited            
	27 Maple Street
	Milford MA  01757-3650
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type F
	Trade Name:
	Orphan Designation:
	Treatment of essential blepharospasm.
	Designation 
	12/5/1991	Sponsor and Address
	Marketing Exclusivity 	Ipsen Limited            (name changed from Porton International Inc)
	27 Maple Street
	Milford MA  01757-3650
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulism immune globulin	Indicated for treatment of infant botulism caused by type A or type B 
	Clostridium botulinum. 
	Trade Name:
	BabyBIG 	Orphan Designation:
	Treatment of infant botulism.
	Designation 
	1/31/1989	Sponsor and Address
	Marketing Exclusivity 	California Department of Health Services
	10/23/2003	2151 Berkeley Way
	Berkeley CA  94704-1011
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Bovine colostrum
	Trade Name:
	Orphan Designation:
	Treatment of AIDS-related diarrhea.
	Designation 
	11/19/1990	Sponsor and Address
	Marketing Exclusivity 	Hastings, Donald DVM
	1030 North Parkview Drive
	Bismarck ND  58501 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bovine immunoglobulin concentrate, 
	Cryptosporidium parvum
	Trade Name:
	Sporidin-G	Orphan Designation:
	Treatment and symptomatic relief of Cryptosporidium parvum infection of 
	the gastrointestinal tract in immunocompromised patients.
	Designation 
	3/1/1994	Sponsor and Address
	Marketing Exclusivity 	GalaGen, Inc.
	4001 Lexington Avenue North
	Arden Hills MN  55126 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bovine whey protein concentrate
	Trade Name:
	Immuno-C	Orphan Designation:
	Treatment of cryptosporidiosis caused by the presence of Cryptosporidium 
	parvum in the gastrointestinal tract of patients who are 
	Designation 	immunodeficient/immunocompromised or immunocompetent.
	9/30/1993	Sponsor and Address
	Marketing Exclusivity 	Biomune Systems, Inc.
	540 Arapeen Drive, Suite 202
	Salt Lake City UT  84108 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Branched chain amino acids
	Trade Name:
	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis.
	Designation 
	12/23/1988	Sponsor and Address
	Marketing Exclusivity 	Mount Sinai Medical Center
	One Gustave L. Levy Place
	New York NY  10029 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Brimonidine
	Trade Name:
	Alphagan	Orphan Designation:
	Treatment of anterior ischemic optic neuropathy.
	Designation 
	2/7/2000	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	2525 Dupont Dr.
	P.O. Box 19534
	Irvine CA  92623-9534
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Brivaracetam
	Trade Name:
	Orphan Designation:
	Treatment of symtomatic myoclonus
	Designation 
	10/5/2005	Sponsor and Address
	Marketing Exclusivity 	UCB Pharma, Inc.
	1950 Lake Park Drive
	Smyra GA  30080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Brivudin
	Trade Name:
	Orphan Designation:
	Adjunct treatment of pancreatic cancer
	Designation 
	11/15/2007	Sponsor and Address
	Marketing Exclusivity 	SciClone Pharmaceuticals, Inc.
	901 Mariner's Island Blvd.
	San Mateo CA  94404 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bromhexine
	Trade Name:
	Bisolvon	Orphan Designation:
	Treatment of mild to moderate keratoconjunctivitis sicca in patients with 
	Sjogren's syndrome.
	Designation 
	5/15/1989	Sponsor and Address
	Marketing Exclusivity 	Boehringer Ingelheim Pharmaceuticals, Inc.
	900 Ridgebury Road, Box 368
	Ridgefield CT  06877-0368
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Broxuridine
	Trade Name:
	Broxine/Neomark	Orphan Designation:
	Radiation sensitizer in the treatment of primary brain tumors.
	Designation 
	9/18/1995	Sponsor and Address
	Marketing Exclusivity 	NeoPharm, Inc.
	225 East Deerpath, Suite 250
	Lake Forest IL  60045 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	bryostatin-1
	Trade Name:
	Orphan Designation:
	For use in combination with paclitaxel in the treatment of esophageal 
	cancer
	Designation 
	12/3/2001	Sponsor and Address
	Marketing Exclusivity 	GPC Biotech, Inc.
	610 Lincoln Street
	Waltham MA  02451 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Buffered intrathecal electrolyte/dextrose injection	For the intrathecal administration of methotrexate and cytarabine for the 
	prevention or treatment of meningeal leukemia and lymphocytic lymphoma.
	Trade Name:
	Elliotts B Solution	Orphan Designation:
	For use as a diluent in the intrathecal administration of methotrexate and 
	cytarabine for the prevention or treatment meningeal leukemia and 
	Designation 	lymphocytic lymphoma.
	8/24/1994	Sponsor and Address
	Marketing Exclusivity 	QOL Medical, LLC
	9/27/1996	12419  198th Drive, NE
	Woodinville WA  98072 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Buffered Ursodeoxycholic Acid
	Trade Name:
	Ursocarb	Orphan Designation:
	For the treatment of pruritus in patients with Alagille Syndrome
	Designation 
	9/3/2004	Sponsor and Address
	Marketing Exclusivity 	Digestive Care, Inc.
	1120 Win Drive
	Bethlehem PA  18017 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Buprenorphine hydrochloride	Treatment of opioid dependence in patients 16 years of age or older
	Trade Name:
	Subutex	Orphan Designation:
	Treatment of opiate addiction in opiate users.
	Designation 
	6/15/1994	Sponsor and Address
	Marketing Exclusivity 	Reckitt Benckiser  Pharmaceuticals, Inc.
	10/8/2002	1901 Huguenot Road
	Richmond VA  23235 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Buprenorphine in combination with naloxone	Treatment of opioid dependence in patients 16 years of age or older
	Trade Name:
	Suboxone	Orphan Designation:
	Treatment of opiate addiction in opiate users.
	Designation 
	10/27/1994	Sponsor and Address
	Marketing Exclusivity 	Reckitt Benckiser Pharmaceuticals, Inc.
	10/8/2002	1901 Huguenot Road
	Richmond VA  23235 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Busulfan	For use in combination with cyclophosphamide as a conditioning regimen 
	prior to allogeneic hematopoietic progenitor cell transplantation for chronic
	 myelogenous leukemia.  
	Trade Name:
	Busulfex	Orphan Designation:
	As preparative therapy in the treatment of malignancies with bone marrow 
	transplantation.
	Designation 
	7/28/1994	Sponsor and Address
	Marketing Exclusivity 	Otsuka Pharmaceutical Company
	2/4/1999
	Tokyo
	    
	JAPAN
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Busulfan
	Trade Name:
	Spartaject	Orphan Designation:
	For use as preparative therapy for malignancies treated with bone marrow 
	transplantation.
	Designation 
	4/21/1994	Sponsor and Address
	Marketing Exclusivity 	Sparta Pharmaceuticals, Inc.
	111 Rock Road
	Horsham PA  19044-2310
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Busulfan
	Trade Name:
	Spartajet-Busulfan	Orphan Designation:
	Intrathecal therapy for neoplastic meningitis
	Designation 
	3/5/2001	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	4140 Dublin Boulevard
	Dublin CA  94568 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	busulfan
	Trade Name:
	Partaject	Orphan Designation:
	Preparative therapy for pediatric patients undergoing bone marrow 
	transplantation
	Designation 
	11/25/2002	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	4140 Dublin Blvd
	Suite 200
	Dublin CA  94568 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Busulfan
	Trade Name:
	Spartaject	Orphan Designation:
	Treatment of primary brain malignancies.
	Designation 
	7/7/1997	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	Two Annabel Lane, Suite 220
	San Ramon CA  94583 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Buthionine sulfoxamine
	Trade Name:
	Orphan Designation:
	For use in children as a modulator of chemotherapy for the treatment of 
	pediatric patients with neuroblastoma
	Designation 
	10/5/2005	Sponsor and Address
	Marketing Exclusivity 	USC-CHLA Institute for Pediatric Clinical Research
	Childrens Hospital of Los Angeles MS 55
	Los Angeles CA  90027 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Buthionine sulfoxamine
	Trade Name:
	Orphan Designation:
	Use as a modulator of chemotherapy for the treatment of pediatric patients 
	with primary malignant brain tumors
	Designation 
	10/5/2005	Sponsor and Address
	Marketing Exclusivity 	USC-CHLA Institute for Pediatric Clinical Research
	Childrens Hospital of Los Angeles
	4650 Sunset Blvd, MS 55
	Los Angeles CA  90027 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Butyrylcholinesterase
	Trade Name:
	Orphan Designation:
	Treatment of post-surgical apnea.
	Designation 
	9/30/1992	Sponsor and Address
	Marketing Exclusivity 	Shire Laboratories Inc.
	1550 East Gude Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Butyrylcholinesterase
	Trade Name:
	Orphan Designation:
	For the reduction and clearance of toxic blood levels of cocaine 
	encountered during a drug overdose.
	Designation 
	3/25/1992	Sponsor and Address
	Marketing Exclusivity 	Shire Laboratories Inc.
	1550 East Gude Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	BW 12C
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell disease.
	Designation 
	10/23/1987	Sponsor and Address
	Marketing Exclusivity 	Burroughs Wellcome Company
	3030 Cornwallis Road
	P.O. Box 12700
	Research Triangle Pk NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	C1 esterase inhibitor (human)
	Trade Name:
	Orphan Designation:
	Treatment of angioedema 
	Designation 
	7/16/2004	Sponsor and Address
	Marketing Exclusivity 	Lev Pharmaceuticals, Inc.
	236 Old Lancaster Road
	Merion Station PA  19066 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	C1 esterase inhibitor (human)
	Trade Name:
	Orphan Designation:
	Treatment and prevention of angioedema caused by C1-esterase inhibitor 
	deficiency.
	Designation 
	8/21/1996	Sponsor and Address
	Marketing Exclusivity 	Alpha Therapeutic Corporation
	5555 Valley Boulevard
	Los Angeles CA  90032 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	C1-esterase-inhibitor, human, pasteurized
	Trade Name:
	Berinert P	Orphan Designation:
	Prevention and/or treatment of acute attacks of hereditary angioedema.
	Designation 
	10/16/1992	Sponsor and Address
	Marketing Exclusivity 	CSL Behring L.L.C.
	1020 First Ave.
	PO Box 61501
	King of Prussia PA  19406-0901
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	C1-inhibitor
	Trade Name:
	C1-inhibitor (human) vapor heated, Immuno	Orphan Designation:
	Prevention of acute attacks of angioedema, including short-term 
	prophylaxis for patients requiring dental or other surgical procedures.
	Designation 
	8/30/1990	Sponsor and Address
	Marketing Exclusivity 	Baxter Healthcare Corp.
	One Baxter Way
	Westlake Village CA  91362 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	C1-inhibitor
	Trade Name:
	C1-inhibitor (human) vapor heated, Immuno	Orphan Designation:
	Treatment of acute attacks of angioedema.
	Designation 
	8/30/1990	Sponsor and Address
	Marketing Exclusivity 	Baxter Healthcare Corp.
	Hyland Division (Baxter Hyland)
	550 North Brand Blvd.
	Glendale CA  91203 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	cAC10-vcMMAE (4)
	Trade Name:
	Orphan Designation:
	Treatment of Hodgkin's lymphoma.
	Designation 
	1/30/2007	Sponsor and Address
	Marketing Exclusivity 	Seattle Genetics, Inc.
	21823 30th Drive Southeast
	Bothell WA  98021 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Caffeine	Short term treatment of apnea of prematurity in infants between 28 and less
	 than 33 weeks gestational age.  
	Trade Name:
	Cafcit	Orphan Designation:
	Treatment of apnea of prematurity.
	Designation 
	9/20/1988	Sponsor and Address
	Marketing Exclusivity 	O.P.R. Development, L.P.
	9/21/1999	1501 Wakarusa Drive
	Lawrence KS  66047 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Calcitonin salmon nasal spray
	Trade Name:
	Miacalcin Nasal Spray	Orphan Designation:
	Treatment of symptomatic Paget's disease (osteitis deformans).
	Designation 
	10/29/1990	Sponsor and Address
	Marketing Exclusivity 	Sandoz Pharmaceuticals Corp.
	59 Route 10
	East Hanover NJ  07936 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Calcitonin-human for injection
	Trade Name:
	Cibacalcin	Orphan Designation:
	Treatment of symptomatic Paget's disease (osteitis deformans).
	Designation 
	1/20/1987	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceutical Corporation
	10/31/1986	59 Route 10
	East Hanover NJ  07936 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Calcium acetate
	Trade Name:
	Phos-Lo	Orphan Designation:
	Treatment of hyperphosphatemia in end stage renal failure.
	Designation 
	12/22/1988	Sponsor and Address
	Marketing Exclusivity 	Braintree Laboratories
	12/10/1990	60 Columbian Street
	P.O. Box 361
	Braintree MA  02184 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Calcium acetate
	Trade Name:
	Orphan Designation:
	Treatment of hyperphosphatemia in end stage renal disease.
	Designation 
	6/27/1989	Sponsor and Address
	Marketing Exclusivity 	Pharmedic Company
	28101 Ballard Road, Suite F
	Lake Forest IL  60045 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Calcium carbonate
	Trade Name:
	R & D calcium carbonate/600	Orphan Designation:
	Treatment of hyperphosphatemia in patients with end stage renal disease.
	Designation 
	6/6/1990	Sponsor and Address
	Marketing Exclusivity 	R & D Laboratories, Inc.
	4204 Glencoe Avenue
	Marina Del Rey CA  90292 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Calcium gluconate
	Trade Name:
	Calgonate	Orphan Designation:
	For use as a wash for hydrofluoric acid spills on human skin.
	Designation 
	11/20/1997	Sponsor and Address
	Marketing Exclusivity 	Calgonate Corp.
	190 Commerce Drive
	Warwick RI  02886 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Calcium gluconate gel
	Trade Name:
	H-F Gel	Orphan Designation:
	For use in the emergency topical treatment of hydrogen fluoride 
	(hydrofluoric acid) burns.
	Designation 
	5/21/1991	Sponsor and Address
	Marketing Exclusivity 	LTR Pharmaceuticals, Inc.
	145 Sakonnet Blvd.
	Narragansett RI  02882 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Calcium gluconate gel 2.5%
	Trade Name:
	Orphan Designation:
	Emergency topical treatment of hydrogen fluoride (hydrofluoric acid) burns.
	Designation 
	9/10/1990	Sponsor and Address
	Marketing Exclusivity 	Paddock Laboratories, Inc.
	3940 Quebec Avenue North
	Minneapolis MN  55427 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Calfactant
	Trade Name:
	Infasurf	Orphan Designation:
	Acute respiratory distress syndrome (ARDS)
	Designation 
	9/5/2000	Sponsor and Address
	Marketing Exclusivity 	Pneuma Partners, LLC
	1576 Sweet Home Road
	Amherst NY  14228 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Capsaicin
	Trade Name:
	Orphan Designation:
	Treatment of postherpetic neuralgia.
	Designation 
	8/3/2005	Sponsor and Address
	Marketing Exclusivity 	TheraQuest Biosciences, LLC
	146 Medinah Drive
	Blue Bell PA  19422-3212
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Capsaicin
	Trade Name:
	Orphan Designation:
	Treatment of intermetatarsal neuroma (Morton's Neuroma) that does not 
	respond to conservative treatment and requires either neurectomy or 
	Designation 	neurolysis
	9/29/2006	Sponsor and Address
	Marketing Exclusivity 	Anesiva, Inc.
	650 Gateway Blvd
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	capsaicin
	Trade Name:
	Orphan Designation:
	Treatment of erythromelalgia
	Designation 
	10/23/2002	Sponsor and Address
	Marketing Exclusivity 	NeurogesX, Inc.
	981F Industrial Road
	San Carlos CA  94070 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Capsaicin
	Trade Name:
	Orphan Designation:
	Treatment of painful HIV-associated neuropathy
	Designation 
	5/2/2003	Sponsor and Address
	Marketing Exclusivity 	NeurogesX, Inc.
	San Carlos Business Park
	981F Industrial Road
	San Carols CA  94070-4117
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Carbamylglutamic acid
	Trade Name:
	Orphan Designation:
	Treatment of N-acetylglutamate synthetase deficiency. 
	Designation 
	1/20/1998	Sponsor and Address
	Marketing Exclusivity 	Orphan Europe
	Immeuble "Le Guillaumet"
	60, avenue du General de Gaulle 
	    
	FRANCE
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Carbovir
	Trade Name:
	Orphan Designation:
	Treatment of persons with AIDS and in patients with symptomatic HIV 
	infection and a CD4 count less than 200/mm3.
	Designation 
	12/13/1989	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	carfilzomib
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	1/18/2008	Sponsor and Address
	Marketing Exclusivity 	Proteolix, Inc.
	333 Allerton Avenue
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Carmustine
	Trade Name:
	Orphan Designation:
	Treatment of intracranial malignancies.  
	Designation 
	7/3/2000	Sponsor and Address
	Marketing Exclusivity 	Direct Therapeutics, Inc.
	460 Seaport Court
	Suite 220
	Redwood CA  94063 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cascara sagrada fluid extract
	Trade Name:
	Orphan Designation:
	Treatment of oral drug overdosage to speed lower bowel evacuation.
	Designation 
	3/21/1989	Sponsor and Address
	Marketing Exclusivity 	Intramed Corporation
	102 Tremont Way
	Augusta GA  30907 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Catumaxomab
	Trade Name:
	Removab	Orphan Designation:
	Treatment of ovarian cancer
	Designation 
	6/9/2006	Sponsor and Address
	Marketing Exclusivity 	Fresenius Biotech North America, Inc.
	99 Hayden Avenue
	Lexington MA  02420-9192
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	CD4 human truncated 369 AA polypeptide
	Trade Name:
	Soluble T4	Orphan Designation:
	Treatment of acquired immunodeficiency syndrome.
	Designation 
	11/21/1989	Sponsor and Address
	Marketing Exclusivity 	SmithKline Beecham
	Route 23 & Woodmont Ave., P.O. Box 1510
	King Of Prussia PA  19406 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	CD5-T lymphocyte immunotoxin
	Trade Name:
	Xomazyme-H65	Orphan Designation:
	Treatment of graft versus host disease and/or rejection in patients who have
	 received bone marrow transplants.
	Designation 
	8/27/1987	Sponsor and Address
	Marketing Exclusivity 	Xoma Corporation
	2910 Seventh Street
	Berkeley CA  94710 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	CDP571
	Trade Name:
	Orphan Designation:
	Treatment of Crohn's disease.  
	Designation 
	12/11/1997	Sponsor and Address
	Marketing Exclusivity 	Celltech Chiroscience Limited
	216 Bath Road
	Slough  SL1 4EN
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	CDX-110
	Trade Name:
	Orphan Designation:
	Treatment of EGFRvIII-expressing glioblastoma multiforme
	Designation 
	11/19/2007	Sponsor and Address
	Marketing Exclusivity 	Celldex Therapeutics, inc.
	222 Cameron Drive
	Phillipsburg NJ  08865 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ceftriaxone sodium
	Trade Name:
	Rocephin	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis
	Designation 
	3/28/2006	Sponsor and Address
	Marketing Exclusivity 	Mass General Hospital 
	Merit E. Cudkowicz, MD, MSc
	Building 149 13th Street, Room 2274
	Charlestown MA  02129 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Cells produced using the AastromReplicelle System 
	and SC-I Therapy Kit
	Trade Name:
	Orphan Designation:
	For use in patients receiving high dose chemotherapy who are unable to 
	generate an acceptable dose of peripheral blood stem cells and who have 
	Designation 	a sufficient bone marrow aspirate without morphological evidence of tumor
	7/10/2002	Sponsor and Address
	Marketing Exclusivity 	Aastrom Biosciences Incorporated
	P.O. Box 376
	Ann Arbor MI  48106 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cenersen
	Trade Name:
	Aezea	Orphan Designation:
	Treatment of chronic lymphocytic leukemia 
	Designation 
	2/27/2008	Sponsor and Address
	Marketing Exclusivity 	Eleos, Inc.
	One Valmont Plaza - Corporate Headquarters
	Omaha NE  68154 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	cenersen sodium
	Trade Name:
	Orphan Designation:
	Treatment of acute myeloid leukemia
	Designation 
	5/8/2006	Sponsor and Address
	Marketing Exclusivity 	ELEOS, Inc.
	7824 Jackson Street
	Omaha NE  68114 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Centruroides immune F(ab)2
	Trade Name:
	Alacramyn	Orphan Designation:
	Treatment of scorpion envenomations requiring medical attention.
	Designation 
	6/12/2000	Sponsor and Address
	Marketing Exclusivity 	Silanes Laboratories S.A. de C.V.
	Amores #1034 Col Del Valle
	C.P. 03100 Mexico D.F.
	    
	MEXICO
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ceramide trihexosidase/alpha-galactosidase A	For use in patients with Fabry disease to reduce globotriaosylceramide (GL-
	3) deposition in capillary endothelium of the kidney and certain other cell 
	types
	Trade Name:
	Fabrazyme	Orphan Designation:
	Treatment of Fabry's disease.
	Designation 
	1/19/1988	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	4/24/2003	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	cethromycin
	Trade Name:
	Orphan Designation:
	Prophylactic treatment of patients exposed to inhalation anthrax.
	Designation 
	2/28/2007	Sponsor and Address
	Marketing Exclusivity 	Advanced LIfe Sciences, Inc.
	1440 Davey Road
	Woodridge IL  60517 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cetiedil citrate injection
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell disease crisis.
	Designation 
	12/22/1988	Sponsor and Address
	Marketing Exclusivity 	Baker Cummins Pharmaceuticals, Inc.

	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	cetuximab
	Trade Name:
	Erbitux	Orphan Designation:
	Treatment of pancreatic cancer 
	Designation 
	6/15/2007	Sponsor and Address
	Marketing Exclusivity 	ImClone Systems Incorporated
	33 ImClone Drive
	Branchburg NJ  08876 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cetuximab	For use in combination with radiation therapy, for the treatment of locally or
	 regionally advanced squamous cell carcinoma of the head and neck 
	(SCCHN) and for use as a single agent for the treatment of patients with 
	Trade Name:	recurrent or metastatic SCCHN for whom prior platinum-based therapy has 
	Erbitux	Orphan Designation:
	Treatment of squamous cell cancer of the head and neck in patients who 
	express epidermal growth factor receptor.  
	Designation 
	7/3/2000	Sponsor and Address
	Marketing Exclusivity 	ImClone Systems Incorporated
	3/1/2006	33 ImClone Drive
	Branchburg NJ  08876 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Chenodeoxycholic acid
	Trade Name:
	Chenofalk	Orphan Designation:
	Treatment of cerebrotendinous xanthomatosis
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	Dr. Falk Pharma GmbH
	Leinenweberstrasse 5
	9041 Freiburg, GERMANY
	    
	GERMANY
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	chenodeoxycholic acid
	Trade Name:
	Orphan Designation:
	Treatment of cerebrotendinous xanthomatosis
	Designation 
	2/12/2007	Sponsor and Address
	Marketing Exclusivity 	Sigma Tau
	800 South Frederik Avenue, Suite 300
	Gaithersburg MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Chenodiol
	Trade Name:
	Chenix	Orphan Designation:
	For patients with radiolucent stones in well opacifying gallbladders, in 
	whom elective surgery would be undertaken except for the presence of 
	Designation 	increased surgical risk due to systemic disease or age.
	9/21/1984	Sponsor and Address
	Marketing Exclusivity 	Solvay
	7/28/1983	901 Sawyer Road
	Marietta GA  30062 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Chimeric (human-murine) G250 IgG monoclonal 
	antibody
	Trade Name:
	Orphan Designation:
	Treatment of renal cell carcinoma.  
	Designation 
	7/24/2000	Sponsor and Address
	Marketing Exclusivity 	Wilex Biotechnology GmbH
	Grillparzerstrasse 10B
	81675 Munich
	    
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	chimeric (murine-human) IgG1 mAb against IL-6
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	10/11/2005	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Chimeric (murine-human) IgG1k monoclonal 
	antibody against interleukin-6
	Trade Name:
	Orphan Designation:
	Treatment of Castleman's disease
	Designation 
	5/26/2006	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Chimeric monoclonal antibodies 
	Trade Name:
	Orphan Designation:
	For treatment of shiga-toxin producing bacterial infection.
	Designation 
	10/4/2005	Sponsor and Address
	Marketing Exclusivity 	Thallion Pharmaceuticals, Inc.
	7150 Alexander-Fleming
	Montreal, Quebec, H4S 2C8
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Chimeric monoclonal antibody to mesothelin
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	10/31/2006	Sponsor and Address
	Marketing Exclusivity 	Morphotek, Inc.
	210 Welsh Pool Road
	Exton PA  19341 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Chimeric M-T412 (human-murine) IgG monoclonal 
	anti-CD4
	Trade Name:
	Orphan Designation:
	Treatment of multiple sclerosis.
	Designation 
	6/5/1991	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	244 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Chimeric, humanized monoclonal antibody to 
	staphylococcus
	Trade Name:
	Orphan Designation:
	Prophylaxis of Staphylococcus epidermidis sepsis in low birth weight (1500 
	grams or less) infants.
	Designation 
	8/3/2000	Sponsor and Address
	Marketing Exclusivity 	Biosynexus, Inc.
	9298 Gaither Road
	Rockville MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Chlorhexidine gluconate mouthrinse
	Trade Name:
	Peridex	Orphan Designation:
	For use in the amelioration of oral mucositis associated with cytoreductive 
	therapy used in conditioning patients for bone marrow transplantation 
	Designation 	therapy.
	8/18/1986	Sponsor and Address
	Marketing Exclusivity 	Procter & Gamble Company
	Sharon Wood Technical Center
	11370 Reed Hartman Highway
	Cincinnati OH  45241 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Chlorotoxin
	Trade Name:
	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	12/18/2007	Sponsor and Address
	Marketing Exclusivity 	TransMolecular, Inc.
	840 Memorial Drive
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	cholic acid (3 alpha, 7 alpha, 12 alpha trihydroxy 5-
	beta cholanolic acid)
	Trade Name:
	Falkochol	Orphan Designation:
	Treatment of inborn errors of cholesterol and bile acid synthesis and  
	metabolism
	Designation 
	7/18/2003	Sponsor and Address
	Marketing Exclusivity 	Cincinnati Children's Hospital Medical Center
	3333 Burnet Ave.
	MLC 5006
	Cincinnati OH  45229-3039
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Choline chloride
	Trade Name:
	IntraChol	Orphan Designation:
	Prevention and/or treatment of choline deficiency in patients on long-term 
	parenteral nutrition
	Designation 
	7/20/2006	Sponsor and Address
	Marketing Exclusivity 	Alan L. Buchman, M.D., M.S.P.H.
	Feinberg School of Medicine, Dept. of Gastroentero
	676 N. St. Clair St., Suite 1400
	Chicago IL  60611 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Choline chloride
	Trade Name:
	Intrachol	Orphan Designation:
	Treatment of choline deficiency, specifically the choline deficiency, 
	hepatic steatosis, and cholestasis, associated with long-term parenteral 
	Designation 	nutrition.
	2/10/1994	Sponsor and Address
	Marketing Exclusivity 	Bioniche Pharma USA LLC
	272 E. Deerpath Road
	Suite 304
	Lake Forest IL  60045 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Chondrocyte-alginate gel suspension
	Trade Name:
	Orphan Designation:
	For use in correcting vesicoureteral reflux in the pediatric population.
	Designation 
	12/1/1997	Sponsor and Address
	Marketing Exclusivity 	Curis, Inc.
	61 Moulton Street
	Cambridge MA  02138 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Chondroitinase
	Trade Name:
	Orphan Designation:
	Treatment of patients undergoing vitrectomy.
	Designation 
	2/9/1995	Sponsor and Address
	Marketing Exclusivity 	Bausch & Lomb Pharmaceuticals, Inc.
	8500 Hidden River Pkwy.
	Tampa FL  33637 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	cilengitide
	Trade Name:
	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	5/27/2005	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ciliary neurotrophic factor
	Trade Name:
	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis.
	Designation 
	1/30/1992	Sponsor and Address
	Marketing Exclusivity 	Regeneron Pharmaceuticals Inc
	777 Old Saw Mill River Road
	Tarrytown NY  10591 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ciliary neurotrophic factor, recombinant human
	Trade Name:
	Orphan Designation:
	Treatment of motor neuron disease (including amyotrophic lateral sclerosis,
	 progressive muscular atrophy, progressive bulbar palsy, and primary lateral 
	Designation 	sclerosis).
	5/8/1992	Sponsor and Address
	Marketing Exclusivity 	Syntex-Synergen Neuroscience
	3200 Walnut Street
	Boulder CO  80301 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ciliary neurotrophic factor, recombinant human
	Trade Name:
	Orphan Designation:
	Treatment of spinal muscular atrophies.
	Designation 
	4/2/1992	Sponsor and Address
	Marketing Exclusivity 	Syntex-Synergen Neuroscience
	3200 Walnut Street
	Boulder CO  80301 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	cinacalcet	Treatment of hypercalcemia in patients with parathyroid carcinoma
	Trade Name:
	Sensipar	Orphan Designation:
	Treatment of hypercalcemia in patients with parathyroid carcinoma
	Designation 
	5/12/2003	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	3/8/2004
	One Amgen Center Drive
	Thousand Oaks CA  91320-1799
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cisplatin in liposomal formulation
	Trade Name:
	SLIT Cisplatin for inhalation	Orphan Designation:
	Treatment of osteogenic sarcoma metastatic to the lung
	Designation 
	3/20/2007	Sponsor and Address
	Marketing Exclusivity 	Transave, Inc.
	11 Deer Park Drive
	Monmouth Junction NJ  08852-1923
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cisplatin/epinephrine
	Trade Name:
	IntraDose	Orphan Designation:
	Treatment of metastatic malignant melanoma.
	Designation 
	9/7/2000	Sponsor and Address
	Marketing Exclusivity 	Matrix Pharmaceutical, Inc.
	34700 Campus Drive
	Fremont CA  94555-3612
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cisplatin/epinephrine
	Trade Name:
	IntraDose	Orphan Designation:
	Treatment of squamous cell carcinoma of the head and neck.
	Designation 
	4/3/2000	Sponsor and Address
	Marketing Exclusivity 	Matrix Pharmaceutical, Inc.
	34700  Campus Drive
	Fremont CA  94555-3612
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Citric acid, glucono-delta-lactone and magnesium 
	carbonate
	Trade Name:
	Renacidin Irrigation	Orphan Designation:
	Treatment of renal and bladder calculi of the apatite or struvite variety.
	Designation 
	8/28/1989	Sponsor and Address
	Marketing Exclusivity 	United-Guardian, Inc.
	10/2/1990	P.O. Box 2500
	Smithtown NY  11787 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Civamide
	Trade Name:
	Zucapsaicin	Orphan Designation:
	Treatment of postherpetic neuralgia of the trigeminal nerve
	Designation 
	12/9/2002	Sponsor and Address
	Marketing Exclusivity 	Winston Laboratories, Inc.
	100 Fairway Drive, Suite 134
	Vernon Hills IL  60061 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cladribine
	Trade Name:
	Leustatin	Orphan Designation:
	Treatment of acute myeloid leukemia.
	Designation 
	7/20/1990	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical Research & Dev., LLC
	920 US Highway 202
	P.O. Box 300
	Raritan NJ  08869 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cladribine
	Trade Name:
	Leustatin Injection	Orphan Designation:
	Treatment of hairy cell leukemia.
	Designation 
	11/15/1990	Sponsor and Address
	Marketing Exclusivity 	R. W. Johnson Pharmaceutical Research Institute
	2/26/1993	Route 202, P.O. Box 300
	Raritan NJ  08869 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cladribine
	Trade Name:
	Leustatin Injection	Orphan Designation:
	Treatment of chronic lymphocytic leukemia.
	Designation 
	12/31/1990	Sponsor and Address
	Marketing Exclusivity 	R. W. Johnson Pharmaceutical Research Institute
	1125 Tenton-Harbourton Road
	P. O. Box 200
	Titusville NJ  08560 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cladribine
	Trade Name:
	Mylinax	Orphan Designation:
	Treatment of the chronic progressive form of multiple sclerosis.
	Designation 
	4/19/1994	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical R & D, LLC
	920 Route 202
	PO Box 300
	Raritan NJ  08869-0602
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Cladribine
	Trade Name:
	Leustatin Injection	Orphan Designation:
	Treatment of non-Hodgkin's lymphoma.
	Designation 
	4/19/1993	Sponsor and Address
	Marketing Exclusivity 	Ortho Biotech Oncology Research & Development
	Unit of J & J Pharmaceutical Research & Dev., LLC
	920 Route 202 South, P.O. Box 300
	Raritan NJ  08869-0602
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Clazosentan
	Trade Name:
	Erajet	Orphan Designation:
	Treatment of cerebral vasospasm following subarachnoid hemorrhage
	Designation 
	2/16/2006	Sponsor and Address
	Marketing Exclusivity 	Actelion Pharmaceuticals Ltd.
	Gewerbestrasse 16

	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Clindamycin
	Trade Name:
	Cleocin	Orphan Designation:
	Prevention of Pneumocystis carinii pneumonia in AIDS patients.
	Designation 
	10/28/1988	Sponsor and Address
	Marketing Exclusivity 	Pfizer Inc.
	235 East 42nd Street 
	150-3-46
	New York  NY  10017 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Clindamycin
	Trade Name:
	Cleocin	Orphan Designation:
	Treatment of Pneumocystis carinii pneumonia associated with AIDS 
	patients.
	Designation 
	10/28/1988	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	7000 Portage Road
	Unit 0633-298-113
	Kalamazoo MI  49001-0199
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Clindamycin hydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of sarcoidosis
	Designation 
	8/9/2006	Sponsor and Address
	Marketing Exclusivity 	Autoimmunity Research Foundation
	3423 Hill Canyon Avenue
	Thousand Oaks CA  91360 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	clobazam
	Trade Name:
	Orphan Designation:
	Treatment of Lennox-Gastaut Syndrome.
	Designation 
	12/18/2007	Sponsor and Address
	Marketing Exclusivity 	Ovation Pharmaceuticals, Inc.
	Four Parkway North
	Deerfield  IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	clofarabine
	Trade Name:
	Clofarex	Orphan Designation:
	Treatment of acute myelogenous leukemia
	Designation 
	3/14/2002	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corp (Ilex Products, Inc.)
	4545 Horizon Hill Blvd.
	San Antonio TX  78229-2263
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	clofarabine	Treatment of pediatric patients 1 to 21 years old with relapsed or refractory 
	acute lymphoblastic leukemia after at least two prior regimens
	Trade Name:
	Clolar	Orphan Designation:
	Treatment of acute lymphoblastic leukemia
	Designation 
	2/7/2002	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	12/28/2004	4545 Horizon Hill Blvd.
	San Antonio TX  78229-2263
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Clofazimine
	Trade Name:
	Lamprene	Orphan Designation:
	Treatment of lepromatous leprosy, including dapsone-resistant lepromatous
	 leprosy and lepromatous leprosy complicated by erythema nodosum 
	Designation 	leprosum.
	6/11/1984	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceutical Corporation
	12/15/1986	59 Route 10
	East Hanover NJ  07936 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Clonazepam
	Trade Name:
	Klonopin	Orphan Designation:
	Treatment of hyperekplexia (startle disease).
	Designation 
	8/4/1994	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Clonazepam Intranasal Spray
	Trade Name:
	Orphan Designation:
	Treatment of recurrent acute repetitive seizures
	Designation 
	12/19/2007	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals, Inc.
	3180 Porter Drive
	Palo Alto CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Clonidine	In combination with opiates for the treatment of severe pain in cancer 
	patients that is not adequately relieved by opioid analgesics alone.
	Trade Name:
	Duraclon	Orphan Designation:
	For continous epidural administration as adjunctive therapy with intraspinal 
	opiates for the treatment of pain in cancer patients tolerant to, or 
	Designation 	unresponsive to, intraspinal opiates.
	1/24/1989	Sponsor and Address
	Marketing Exclusivity 	Roxane Laboratories, Inc.
	10/2/1996	PO Box 16532
	Columbus OH  43216-6532
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Clostridial collagenase
	Trade Name:
	Orphan Designation:
	Treatment of advanced (involutional or residual stage) Dupuytren's disease.
	Designation 
	5/23/1996	Sponsor and Address
	Marketing Exclusivity 	Auxilium Pharmaceuticals, Inc.
	40 Valley Stream Parkway
	Malvern PA  19335 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Clotrimazole
	Trade Name:
	Orphan Designation:
	Topical treatment of children and adults with pouchitis
	Designation 
	6/14/2005	Sponsor and Address
	Marketing Exclusivity 	Effective Pharmaceuticals, Inc.
	150 Broadway
	Suite 1800
	New York NY  10038 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Clotrimazole
	Trade Name:
	Orphan Designation:
	Treatment of Huntington's disease
	Designation 
	3/13/2006	Sponsor and Address
	Marketing Exclusivity 	EnVivo Pharmaceuticals, Inc.
	480 Arsenal Street
	Watertown MA  02472 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Clotrimazole
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell disease.
	Designation 
	4/24/1995	Sponsor and Address
	Marketing Exclusivity 	Brugnara, Carlo M.D.
	The Children's Hospital
	300 Longwood Avenue, Bader 760
	Boston MA  02115 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	c-myb antisense oligodeoxynucleotide
	Trade Name:
	Orphan Designation:
	Treatment of chronic myelogenous leukemia
	Designation 
	2/22/2005	Sponsor and Address
	Marketing Exclusivity 	Genta, Inc.
	Two Connell Drive
	Berkeley Heights NJ  07922 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation factor IX	Prevention and control of bleeding in factor IX deficiency, also known as 
	hemophilia B or Christmas disease.
	Trade Name:
	Mononine	Orphan Designation:
	Replacement treatment and prophylaxis of the hemorrhagic complications 
	of hemophilia B.
	Designation 
	6/27/1989	Sponsor and Address
	Marketing Exclusivity 	Armour Pharmaceutical Company
	8/20/1992	500 Arcola Road, P.O. Box 1200
	Collegeville PA  19426 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation Factor IX (human)
	Trade Name:
	AlphaNine	Orphan Designation:
	For use as replacement therapy in patients with hemophilia B for the 
	prevention and control of bleeding episodes, and during surgery to correct 
	Designation 	defective hemostasis.
	7/5/1990	Sponsor and Address
	Marketing Exclusivity 	Alpha Therapeutic Corporation
	12/31/1990	5555 Valley Boulevard
	Los Angeles CA  90032 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation Factor IX (recombinant)	For the control and prevention of hemorrhagic episodes in patients with 
	hemophilia B (congenital factor IX deficiency and Christmas disease), 
	including control and prevention of bleeding in surgical settings.
	Trade Name:
	BeneFix	Orphan Designation:
	Treatment of hemophilia B.
	Designation 
	10/3/1994	Sponsor and Address
	Marketing Exclusivity 	Genetics Institute, Inc.
	2/11/1997	87 Cambridge Park Drive
	Cambridge MA  02140 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (recombinant)	Prevention of bleeding in surgical interventions or invasive procedures in 
	patients with acquired hemophilia
	Trade Name:
	NovoSeven	Orphan Designation:
	Prevention of bleeding episodes in patients with acquired inhibitors to 
	Factor VIII or Factor IX 
	Designation 
	7/21/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	10/13/2006	100 College Road West
	Princeton  NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (recombinant)
	Trade Name:
	NovoSeven	Orphan Designation:
	Prevention of bleeding episodes in Glanzmann's thrombasthenia 
	Designation 
	6/18/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	100 College Road West
	Princeton  NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (recombinant)	Prevention of bleeding in surgical interventions or invasive procedures in 
	patients with congenital F VII deficiency
	Trade Name:
	NovoSeven	Orphan Designation:
	Prevention of bleeding episodes in patients with congenital Factor VII 
	deficiency
	Designation 
	9/10/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	7/11/2005	100 College Road West
	Princeton  NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation Factor VIIa (Recombinant)	Treatment of bleeding episodes in surgical interventions or invasive 
	procedures in patients with acquired hemophilia
	Trade Name:
	NovoSeven	Orphan Designation:
	Treatment of bleeding episodes in patients with acquired inhibitors to 
	Factor VIII or Factor IX
	Designation 
	7/16/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	10/13/2006	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (recombinant)	Prevention of bleeding in surgical interventions or invasive procedures in 
	hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
	Trade Name:
	NovoSeven	Orphan Designation:
	Prevention of bleeding episodes in patients with hemophilia A or B, with or 
	without inhibitors
	Designation 
	6/18/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	8/12/2005	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (Recombinant)
	Trade Name:
	NovoSeven	Orphan Designation:
	Treatment of bleeding episodes in Glanzmann's thrombasthenia
	Designation 
	6/18/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (recombinant)	Treatment of bleeding episodes in patients with Factor VII Deficiency
	Trade Name:
	NovoSeven	Orphan Designation:
	Treatment of bleeding episodes in patients with congenital factor VII 
	deficiency
	Designation 
	9/10/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	7/11/2005	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation Factor VIIa (Recombinant)
	Trade Name:
	NovoSeven	Orphan Designation:
	Treatment of bleeding in patients experiencing intracranial hemorrhage.
	Designation 
	10/3/2006	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (recombinant)	Treatment of bleeding episodes in hemophilia A or B patients with 
	inhibitors to Factor VIII or Factor IX.  
	Trade Name:
	NovoSeven	Orphan Designation:
	Treatment of bleeding episodes in hemophilia A or B patients with 
	inhibitors to Factor VIII or Factor IX.
	Designation 
	6/6/1988	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	3/25/1999	100 Overlook Center
	Suite 200
	Princeton NJ  08540-7810
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	cobiprostone
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	11/14/2002	Sponsor and Address
	Marketing Exclusivity 	Sucampo Pharmaceuticals, Inc.
	4520 East-West Highway
	Third Floor
	Bethesda MD  20814 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	coccidioidin SD Skin Test Antigen
	Trade Name:
	Orphan Designation:
	For the diagnosis of Coccidioidomycosis.
	Designation 
	12/19/2007	Sponsor and Address
	Marketing Exclusivity 	Allermed Labortories, Inc.
	7203 Convoy Court
	San Diego CA  92111 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coenzyme Q10
	Trade Name:
	Orphan Designation:
	Treatment of Huntington's disease
	Designation 
	3/5/2001	Sponsor and Address
	Marketing Exclusivity 	Integrative Therapeutics, Inc.
	825 Challenger Drive
	Green Bay  WI  54311 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Colchicine
	Trade Name:
	Orphan Designation:
	Treatment of familial Mediterranean fever
	Designation 
	9/25/2007	Sponsor and Address
	Marketing Exclusivity 	AR Scientific, Inc.
	1100 Orthodox Street
	Philadelphia PA  19124 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Colchicine
	Trade Name:
	Orphan Designation:
	Treatment of Behcet's Syndrome
	Designation 
	9/25/2007	Sponsor and Address
	Marketing Exclusivity 	AR Scientific, Inc.
	1100 Orthodox Street
	Philadelphia PA  19124 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Colchicine
	Trade Name:
	Orphan Designation:
	For arresting the progression of neurologic disability caused by chronic 
	progressive multiple sclerosis.
	Designation 
	12/9/1985	Sponsor and Address
	Marketing Exclusivity 	Pharmacontrol Corporation
	661 Palisade Ave., P.O. Box 931
	Englewood Cliffs NJ  07632 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Colfosceril palmitate, cetyl alcohol, tyloxapol
	Trade Name:
	Exosurf Neonatal for Intratracheal Suspension	Orphan Designation:
	Treatment of established hyaline membrane disease at all gestational ages.
	Designation 
	10/20/1989	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	8/2/1990	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Colfosceril palmitate, cetyl alcohol, tyloxapol
	Trade Name:
	Exosurf Neonatal for Intratracheal Suspension	Orphan Designation:
	Prevention of hyaline membrane disease, also known as respiratory distress 
	syndrome, in infants born at 32 weeks gestation or less.
	Designation 
	10/20/1989	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	8/2/1990	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Colfosceril palmitate, cetyl alcohol, tyloxapol
	Trade Name:
	Exosurf	Orphan Designation:
	Treatment of adult respiratory distress syndrome.
	Designation 
	1/11/1993	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline
	5 Moore Drive
	P.O. Box 13398
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Collagenase (lyophilized) for injection
	Trade Name:
	Plaquase	Orphan Designation:
	Treatment of Peyronie's disease. 
	Designation 
	3/12/1996	Sponsor and Address
	Marketing Exclusivity 	Auxilium Pharmaceuticals, Inc.
	40 Valley Stream Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Combretastatin A4 phosphate
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer
	Designation 
	5/8/2006	Sponsor and Address
	Marketing Exclusivity 	OXiGENE, Inc.
	230 Third Avenue
	Waltham MA  02451 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Combretastatin A4 Phosphate
	Trade Name:
	Orphan Designation:
	Treatment of anaplastic thyroid cancer, medullary thyroid cancer, and stage
	 IV papillary or follicular thyroid cancer
	Designation 
	7/23/2003	Sponsor and Address
	Marketing Exclusivity 	OXiGENE, Inc
	321 Arsenal Street
	Watertown MA  02472 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	conjugate of human transferrin and a mutant 
	diphtheria toxin (CRM 107)
	Trade Name:
	TransMID	Orphan Designation:
	Treatment of malignant tumors of the central nervous system
	Designation 
	12/3/2001	Sponsor and Address
	Marketing Exclusivity 	Xenova Biomedix Limited
	957 Budkingham Avenue 
	Slough
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	conjugated bile acids
	Trade Name:
	COBARTin	Orphan Designation:
	Treatment of steatorrhea in patients with short bowel syndrome
	Designation 
	7/18/2003	Sponsor and Address
	Marketing Exclusivity 	Jarrow Formulas, Inc.
	1824 S. Robertson Blvd.
	Los Angeles CA  90035-4317
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Contulakin-G
	Trade Name:
	Orphan Designation:
	Intrathecal treatment of neuropathic pain associated with spinal cord injury
	Designation 
	7/7/2005	Sponsor and Address
	Marketing Exclusivity 	Cognetix, Inc.
	421 Wakara Way
	Salt Lake City UT  84108 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cordycepin
	Trade Name:
	Orphan Designation:
	Treatment of TdT-positive acute lymphocytic leukemia
	Designation 
	7/5/2007	Sponsor and Address
	Marketing Exclusivity 	OncoVista, Inc.
	14785 Omicron Drive
	San Antonio TX  78245 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Corticorelin ovine triflutate	To differentiate between pituitary and ectopic production of ACTH in 
	patients with ACTH-dependent Cushing's syndrome.
	Trade Name:
	Acthrel	Orphan Designation:
	For use in differentiating pituitary and ectopic production of ACTH in 
	patients with ACTH-dependent Cushings syndrome.
	Designation 
	11/24/1989	Sponsor and Address
	Marketing Exclusivity 	Ferring Laboratories, Inc.
	5/23/1996	400 Rella Boulevard, Suite 201
	Suffern NY  10901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Corticotropin-releasing factor, human
	Trade Name:
	Xerecept	Orphan Designation:
	Treatment of peritumoral brain edema.
	Designation 
	4/6/1998	Sponsor and Address
	Marketing Exclusivity 	Neurobiological Technologies, Inc.
	1387 Marina Way South
	Richmond CA  94804 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coumarin
	Trade Name:
	Onkolox	Orphan Designation:
	Treatment of renal cell carcinoma.
	Designation 
	12/22/1994	Sponsor and Address
	Marketing Exclusivity 	Drossapharm LTD
	4002 Basel

	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coxsackievirus A21
	Trade Name:
	Cavatak	Orphan Designation:
	Treatment of stage II (T4), stage III, and stage IV melanoma
	Designation 
	12/15/2005	Sponsor and Address
	Marketing Exclusivity 	Viralytics Limited
	P. O. Box 1045
	Pymble Business Centre
	    
	AUSTRALIA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Creatine
	Trade Name:
	Creapure	Orphan Designation:
	Treatment of Huntington's disease
	Designation 
	10/11/2005	Sponsor and Address
	Marketing Exclusivity 	Avicena Group, Inc.
	228 Hamilton Avenue
	Palo Alto CA  94301 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	creatine
	Trade Name:
	Creapure	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis
	Designation 
	2/12/2002	Sponsor and Address
	Marketing Exclusivity 	Avicena Group, Inc.
	580 California St.
	Suite 1600
	San Francisco CA  94104 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cromolyn sodium
	Trade Name:
	Gastrocrom	Orphan Designation:
	Treatment of mastocytosis.
	Designation 
	3/8/1984	Sponsor and Address
	Marketing Exclusivity 	Fisons Corporation
	12/22/1989	755 Jefferson Rd
	P.O. Box 1710
	Rochester NY  14603 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cromolyn sodium 4% ophthalmic solution
	Trade Name:
	Opticrom 4% ophthalmic solution	Orphan Designation:
	Treatment of vernal keratoconjunctivitis.
	Designation 
	7/24/1985	Sponsor and Address
	Marketing Exclusivity 	Fisons Corporation
	10/3/1984	755 Jefferson Rd.
	P.O. Box 1710
	Rochester NY  14603 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cryptosporidium hyperimmune bovine colostrum IgG 
	concentrate
	Trade Name:
	Orphan Designation:
	Treatment of diarrhea in AIDS patients caused by infection with 
	Cryptosporidium parvum.
	Designation 
	12/30/1991	Sponsor and Address
	Marketing Exclusivity 	ImmuCell Corporation
	56 Evergreen Drive
	Portland ME  04103 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	cultured, partially T-Cell depleted, allogenic thymic 
	tissue for transplantation
	Trade Name:
	Orphan Designation:
	As a therapy for primary immune deficiency resulting from athymia 
	associated with complete DiGeorge Syndrome
	Designation 
	8/15/2003	Sponsor and Address
	Marketing Exclusivity 	Duke University Medical Center
	Division of Pediatric Allergy & Immunology
	Erwin Road
	Durham NC  27710 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	CY-1503
	Trade Name:
	Cylexin	Orphan Designation:
	Treatment of neonates and infants undergoing cardiopulmonary bypass 
	during surgical repair of congenital heart lesions.
	Designation 
	7/18/1997	Sponsor and Address
	Marketing Exclusivity 	Cytel Corporation
	3525 John Hopkins Court
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	CY-1503
	Trade Name:
	Cylexin	Orphan Designation:
	Treatment of post-ischemic pulmonary reperfusion edema following 
	surgical treatment for chronic thromboembolic pulmonary hypertension.
	Designation 
	12/22/1993	Sponsor and Address
	Marketing Exclusivity 	Cytel Corporation
	3525 John Hopkins Court
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	CY-1899
	Trade Name:
	Orphan Designation:
	Treatment of chronic active hepatitis B infection in HLA-A2 positive 
	patients.
	Designation 
	3/16/1994	Sponsor and Address
	Marketing Exclusivity 	Cytel Corporation
	3525 John Hopkins Court
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cyclo {{(E,Z)-(2S,3R,4R)-3-hydroxy-4-methyl-2-
	(methylamino)nona-6,8-dienoyl}-L-2-aminobytyrl-N-
	methyl-glycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-
	leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-
	L-leucyl-N-methyl-L-valyl}
	Trade Name:
	Orphan Designation:
	Treatment and chronic control of non-infectious posterior, intermediate and
	 pan-uveitis
	Designation 
	12/20/2006	Sponsor and Address
	Marketing Exclusivity 	Lux Biosciences, Inc.
	Hoarborside Financial Center
	Plaza 10, 14th Floor
	Jersey City NJ  07302 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cyclosporin A
	Trade Name:
	Mitogard	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis and its variants
	Designation 
	10/29/2004	Sponsor and Address
	Marketing Exclusivity 	Maas Biolab,LLC
	Tecnology Ventures Corporation Technopolis
	1155 University Blvd., SE
	Albuquerque NM  87106 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Cyclosporine	Kristin Miller, CSO, HFD-590.
	Trade Name:
	Orphan Designation:
	Prophylaxis of organ rejection in patients receiving allogeneic lung 
	transplant
	Designation 
	11/25/2003	Sponsor and Address
	Marketing Exclusivity 	APT Pharmaceuticals, Inc.
	700 Airport Blvd.
	Suite 350
	Burlingame CA  94010 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cyclosporine
	Trade Name:
	Pluminiq	Orphan Designation:
	Treatment of acute rejection in patients requiring allogenic lung transplants
	Designation 
	11/25/2003	Sponsor and Address
	Marketing Exclusivity 	APT Pharmaceuticals, Inc.
	700 Airport Blvd. 
	Suite 350
	Burlingame CA  94010 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cyclosporine 2% ophthalmic ointment
	Trade Name:
	Orphan Designation:
	Treatment of patients at high risk of graft rejection following penetrating 
	keratoplasty.
	Designation 
	8/1/1991	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92623-9534
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cyclosporine 2% ophthalmic ointment
	Trade Name:
	Orphan Designation:
	For use in corneal melting syndromes of known or presumed immunologic 
	etiopathogenesis, including Mooren's ulcer.
	Designation 
	8/1/1991	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92623-9534
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cyclosporine A
	Trade Name:
	Orphan Designation:
	Treatment of vernal keratoconjunctivitis
	Designation 
	5/4/2007	Sponsor and Address
	Marketing Exclusivity 	NOVAGALI Pharma SA
	Batiment Genavenir IV
	F-91058-Evry cedex
	    
	FRANCE
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	cyclosporine A
	Trade Name:
	NOVA22007	Orphan Designation:
	Treatment of herpes simplex virus stromal keratitis
	Designation 
	4/9/2008	Sponsor and Address
	Marketing Exclusivity 	Novagali Pharma S.A.
	1 rue Pierre Fontaine
	91058 Evry cedex
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cyclosporine A implant
	Trade Name:
	Orphan Designation:
	For the prevention of acute rejection in cornea transplant patients
	Designation 
	1/8/2007	Sponsor and Address
	Marketing Exclusivity 	Lux Biosciences, Inc.
	Harborside Financial Center
	Plaza 10, 14th Floor
	Jersey City NJ  07302 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cyclosporine in combination with omega-3 
	polyunsaturated fatty acids
	Trade Name:
	Orphan Designation:
	Prevention of solid organ graft rejection.
	Designation 
	12/6/2000	Sponsor and Address
	Marketing Exclusivity 	RTP Pharma Corporation
	200 Westpark Corporate Center
	4364 South Alston Avenue
	Durham NC  27713-2280
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cyclosporine ophthalmic
	Trade Name:
	Optimmune	Orphan Designation:
	Treatment of severe keratoconjunctivitis sicca associated with Sjogren's 
	syndrome.
	Designation 
	11/9/1988	Sponsor and Address
	Marketing Exclusivity 	University Of Georgia
	College Of Veterinary Medicine
	Department of Small Animal Medicine
	Athens GA  30602 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cyproterone acetate
	Trade Name:
	Androcur	Orphan Designation:
	Treatment of severe hirsutism.
	Designation 
	10/26/1984	Sponsor and Address
	Marketing Exclusivity 	Berlex Laboratories, Inc.
	300 Fairfield Road
	Wayne NJ  07470 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Cys-His-Ala-Val-Cys
	Trade Name:
	Orphan Designation:
	For use in conjunction with melphalen for the treatment of malignant 
	melanoma, AJCC stages IIB, IIC, III and IV
	Designation 
	2/14/2008	Sponsor and Address
	Marketing Exclusivity 	Adherex Technologies, Inc.
	4620 Creekstone Drive
	Durham NC  27703 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	cysteamine
	Trade Name:
	Orphan Designation:
	Treatment of Huntington's disease
	Designation 
	5/9/2008	Sponsor and Address
	Marketing Exclusivity 	Bennu Pharmaceuticals
	9 Commerical Blvd
	Novato CA  94949 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cysteamine
	Trade Name:
	Orphan Designation:
	Treatment of nephropathic cystinosis.
	Designation 
	5/1/1986	Sponsor and Address
	Marketing Exclusivity 	Thoene, Jess  G., M.D.
	University of Michigan Medical School
	300 NIB, 1192 SE
	Ann Arbor MI  48109-0408
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cysteamine	Treatment of nephropathic cystinosis in adults and children.
	Trade Name:
	Cystagon	Orphan Designation:
	Treatment of nephropathic cystinosis.
	Designation 
	1/25/1991	Sponsor and Address
	Marketing Exclusivity 	Mylan Laboratories, Inc.
	8/15/1994	781 Chestnut Ridge Road
	P.O. Box 4310
	Morgantown WV  26504 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cysteamine hydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of corneal cystine crystal accumulation in cystinosis patients.
	Designation 
	8/19/1997	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	800 South Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Cystic fibrosis gene therapy
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	6/30/1992	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	One Mountain Rd.
	P.O. Box 9322
	Framingham MA  01701-9322
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cystic fibrosis Tr gene therapy (recombinant 
	adenovirus)
	Trade Name:
	AdGVCFTR.10	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	3/9/1995	Sponsor and Address
	Marketing Exclusivity 	GenVec, Inc.
	12111 Parklawn Drive
	Rockville MD  20852 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cystic fibrosis transmembrane conductance regulator
	Trade Name:
	Orphan Designation:
	For cystic fibrosis transmembrane conductance regulator protein 
	replacement therapy in cystic fibrosis patients.
	Designation 
	1/14/1992	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	One Mountain Road
	P.O. Box 9322
	Framingham MA  01701-9322
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cystic fibrosis transmembrane conductance regulator 
	gene
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	1/8/1993	Sponsor and Address
	Marketing Exclusivity 	Genetic Therapy, Inc.
	938 Clopper Road
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cytarabine liposomal	Intrathecal treatment of lymphomatous meningitis.
	Trade Name:
	DepoCyt	Orphan Designation:
	Treatment of neoplastic meningitis.
	Designation 
	6/2/1993	Sponsor and Address
	Marketing Exclusivity 	Pacira Pharmaceuticals, Inc.
	4/1/1999	10450 Science Center Drive
	San Diego CA  92121 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	cytarabine liposome
	Trade Name:
	DepoCyt	Orphan Designation:
	Treatment of gliomas
	Designation 
	1/30/2007	Sponsor and Address
	Marketing Exclusivity 	Bruce Frankel, MD
	Medical University of South Carolina
	96 Jonathan Lucas Street, Suite 428 CSB
	Charleston SC  29425 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cytomegalovirus DNA Vaccine 
	w/Copolymer/Benzalkonium Chloride
	Trade Name:
	Orphan Designation:
	For use in prevention of clinically significant CMV viremia, CMV disease 
	and associated complications in at-risk hematopoietic cell transplant and 
	Designation 	solid organ transplant populations
	9/23/2006	Sponsor and Address
	Marketing Exclusivity 	Vical Inc.
	10390 Pacific Center Court
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cytomegalovirus DNA vaccine with plasmids 
	expressing pp65 and gB genes
	Trade Name:
	Orphan Designation:
	Prevention of clinically significant cytomegalovirus (CMV) viremia, CMV 
	disease and asociated complications in at-risk hematopoietic cell transplant
	Designation 	 and solid transplant populations
	6/3/2005	Sponsor and Address
	Marketing Exclusivity 	Vical Incorporated
	10390 Pacific Center Court
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cytomegalovirus immune globulin (human)	#1) Attenuation of primary CMV disease associated with kidney transplant 
	recipients who are seronegative for CMV and who receive a kidney from a 
	CMV seropositve donor; #2)  Prophylaxis of CMV disease associated 
	Trade Name:	transplantation of kidney (all other), lung, liver, pancreas and heart.    
	CytoGam	Orphan Designation:
	Prevention or attenuation of primary cytomegalovirus disease in 
	immunosuppressed recipients of organ transplants.
	Designation 
	8/3/1987	Sponsor and Address
	Marketing Exclusivity 	Massachussetts Public Health Biologic Laboratories
	12/4/1998	305 South Street
	Boston MA  02130-3597
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cytomegalovirus immune globulin intravenous 
	(human)
	Trade Name:
	Orphan Designation:
	For use in conjunction with ganciclovir sodium for the treatment of 
	cytomegalovirus pneumonia in bone marrow transplant patients.
	Designation 
	1/28/1991	Sponsor and Address
	Marketing Exclusivity 	Bayer Corporation
	Pharmaceutical Division, Biological Products
	400 Morgan Lane
	New Haven CT  06516 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Daclizumab	Prophylaxis of acute organ rejection in patients receiving renal transplants, 
	to be used as a part of an immunosuppressive  regimen that includes 
	cyclosporine and corticosteroids.
	Trade Name:
	Zenapax	Orphan Designation:
	Prevention of acute renal allograft rejection.
	Designation 
	3/5/1993	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	12/10/1997	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dantrolene sodium
	Trade Name:
	Dantrium	Orphan Designation:
	Treatment of the neuroleptic malignant syndrome.
	Designation 
	12/14/1987	Sponsor and Address
	Marketing Exclusivity 	Norwich Eaton Pharmaceuticals
	P.O. Box 191
	Norwich NY  13815 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dapsone
	Trade Name:
	Orphan Designation:
	Prophylaxis of toxoplasmosis in severely immunocompromised patients with
	 CD4 counts below 100.
	Designation 
	11/7/1994	Sponsor and Address
	Marketing Exclusivity 	Jacobus Pharmaceutical Company, Inc.
	37 Cleveland Lane
	P.O. Box 5290
	Princeton NJ  08540 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dapsone USP
	Trade Name:
	Dapsone	Orphan Designation:
	For the combination treatment of Pneumocystis carinii pneumonia in 
	conjunction with trimethoprim.
	Designation 
	1/8/1992	Sponsor and Address
	Marketing Exclusivity 	Jacobus Pharmaceutical Company
	37 Cleveland Lane
	P.O. Box 5290
	Princeton NJ  08540 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dapsone USP
	Trade Name:
	Dapsone	Orphan Designation:
	Prophylaxis for Pneumocystis carinii pneumonia.
	Designation 
	12/24/1991	Sponsor and Address
	Marketing Exclusivity 	Jacobus Pharmaceutical Company
	37 Cleveland Lane
	P.O. Box 5290
	Princeton NJ  08540 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Dasatinib	Treatment of adults with Philadelphia chromosome-positive acute 
	lymphoblastic leukemia with resistance or intolerance to prior therapy
	Trade Name:
	Sprycel	Orphan Designation:
	Treatment of Philadelphia-positive acute lymphoblastic leukemia
	Designation 
	11/18/2005	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Company
	6/28/2006	5 Research Parkway
	Wallingford CT  06492 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dasatinib	Treatment of adults with chronic myeloid leukemia with resistance or 
	intolerance to prior therapy including imatinib
	Trade Name:
	Sprycel	Orphan Designation:
	Treatment of chronic myelogenous leukemia
	Designation 
	11/28/2005	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Company
	6/28/2006	5 Research Parkway
	Wallingford CT  06492 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Daunorubicin citrate liposome injection	First line cytotoxic therapy for advanced, HIV related Kaposi's sarcoma. 
	Trade Name:
	DaunoXome	Orphan Designation:
	Treatment of patients with advanced HIV-associated Kaposi's sarcoma.
	Designation 
	5/14/1993	Sponsor and Address
	Marketing Exclusivity 	NeXstar Pharmaceuticals, Inc.
	4/8/1996	650 Cliffside Drive
	San Dimas CA  91773 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	DEAE-rebeccamycin
	Trade Name:
	Orphan Designation:
	Treatment of bile duct tumors 
	Designation 
	3/1/2004	Sponsor and Address
	Marketing Exclusivity 	Helsinn Healthcare SA
	Via Pian Scairolo, 6912 Pazzallo
	Lugano
	    
	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	debrase
	Trade Name:
	Debridase	Orphan Designation:
	Debridement of acute, deep dermal burns in hospitalized patients
	Designation 
	8/20/2003	Sponsor and Address
	Marketing Exclusivity 	MediWound, Ltd.
	3, Azrieli Center
	Triangular Tower 45th Floor
	    
	ISRAEL
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Decitabine
	Trade Name:
	Dacogen	Orphan Designation:
	Treatment of acute myeloid leukemia
	Designation 
	8/4/2006	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma
	6611 Tributary Street
	Baltimore MD  21224-6515
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	decitabine
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell anemia
	Designation 
	9/9/2002	Sponsor and Address
	Marketing Exclusivity 	MGI  CP, d/b/a MGI Pharma
	6611 Tributary Street
	Baltimore MD  21224 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Decitabine
	Trade Name:
	Orphan Designation:
	Treatment of chronic myelogenous leukemia.  
	Designation 
	3/8/1999	Sponsor and Address
	Marketing Exclusivity 	MGI CP, Inc. d/b/a MGI Pharma
	6611 Tributary Street
	Suite 200
	Baltimore MD  21224 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Decitabine	for treatment of patients with myelodysplastic syndromes (MDS) including 
	previously treated and untreated, de novo and secondary MDS of all 
	French-American-British subtypes (refractory anemia, refractory anemia with
	Trade Name:	 ringed sideroblasts, refractory anemia with excess blasts, refractory anemia 
	with excess blasts in transformation, and chronic myelomonocytic leukemia)
	 and intermediate-1, intermediate-2, and high-risk International Prognostic 
	Dacogen	Orphan Designation:
	Treatment of myelodysplastic syndromes.  
	Designation 
	3/8/1999	Sponsor and Address
	Marketing Exclusivity 	MGI CP, Inc. d/b/a MGI Pharma
	5/2/2006	6611 Tributary Street
	Suite 200
	Baltimore MD  21224 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Deferasirox	Treatment of chronic iron overload due to blood transfusions (transfusional 
	hemosiderosis) in patients 2 years of age or older
	Trade Name:
	Exjade	Orphan Designation:
	Treatment of chronic iron overload in patients with transfusion-dependent 
	anemias
	Designation 
	11/21/2002	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	11/2/2005	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	deferiprone
	Trade Name:
	Ferriprox	Orphan Designation:
	Treatment of iron overload in patients with hematologic disorders requiring 
	chronic transfusion therapy
	Designation 
	12/12/2001	Sponsor and Address
	Marketing Exclusivity 	ApoPharma, Inc. A Division of
	Apotex Research Inc.
	Toronto, Canada M9L 1T9
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	deferoxamine-starch conjugate
	Trade Name:
	Orphan Designation:
	Treatment of acute iron poisoning.
	Designation 
	1/28/2005	Sponsor and Address
	Marketing Exclusivity 	Biomedical Frontiers, Inc.
	1095 10th Avenue, SE
	Minneapolis MN  55414 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	defibrotide
	Trade Name:
	Orphan Designation:
	For the prevention of hepatic veno-occlusive disease.
	Designation 
	1/8/2007	Sponsor and Address
	Marketing Exclusivity 	Gentium SpA
	Piazza XX Settembre, 2

	ITALY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Defibrotide
	Trade Name:
	Orphan Designation:
	For the treatment of hepatic veno-occlusive disease
	Designation 
	5/21/2003	Sponsor and Address
	Marketing Exclusivity 	Gentium SpA
	Piazza XX Settembre, 2
	22079 Villa Guardia (CO)
	    
	ITALY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Defibrotide
	Trade Name:
	Orphan Designation:
	Treatment of thrombotic thrombocytopenic purpura.
	Designation 
	7/5/1985	Sponsor and Address
	Marketing Exclusivity 	Crinos International
	Via Belvedere 1
	Villa Guardia, Italy   22079 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Dehydroepiandrosterone
	Trade Name:
	Orphan Designation:
	Treatment of systemic lupus erythematosus (SLE) and the reduction in the 
	use of steroids in steroid-dependent SLE patients.
	Designation 
	7/13/1994	Sponsor and Address
	Marketing Exclusivity 	Genelabs Technologies, Inc.
	505 Penobscot Drive
	Redwood City CA  94063 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dehydroepiandrosterone (DHEA)
	Trade Name:
	Fidelin	Orphan Designation:
	Replacement therapy in individuals with adrenal insufficiency
	Designation 
	8/19/2003	Sponsor and Address
	Marketing Exclusivity 	Paladin Labs, Inc.
	6111 Royalmount Avenue, Suite 102
	Montreal
	Quebec   H4P 2T4    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dehydroepiandrosterone sulfate sodium
	Trade Name:
	Orphan Designation:
	Treatment of serious burns requiring hospitalization.
	Designation 
	1/29/1997	Sponsor and Address
	Marketing Exclusivity 	Pharmadigm, Inc.
	2401 Foothill Drive
	Salt Lake City UT  84109-1405
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dehydroepiandrosterone sulfate sodium
	Trade Name:
	Orphan Designation:
	To accelerate the re-epithelialization of donor sites in those hospitalized 
	burn patients who must undergo autologous skin grafting.
	Designation 
	1/28/1997	Sponsor and Address
	Marketing Exclusivity 	Pharmadigm, Inc.
	2401 Foothill Drive
	Salt Lake City UT  84109-1405
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	denileukin diftitox	Treatment of patients with persistent or recurrent cutaneous T-cell 
	lymphoma whose malignant cells express the CD25 component of the IL-2 
	receptor.
	Trade Name:
	Ontak	Orphan Designation:
	Treatment of patients with Cutaneous T-cell Lymphoma.
	Designation 
	8/21/1996	Sponsor and Address
	Marketing Exclusivity 	Eisai Medical Research, Inc.
	2/5/1999	55 Challenger Road
	Ridgefield Park NJ  07660 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Deslorelin
	Trade Name:
	Somagard	Orphan Designation:
	Designation 
	11/5/1987	Sponsor and Address
	Marketing Exclusivity 	Roberts Pharmaceutical Corp.
	Meridian Center II
	Four Industrial Way West
	Eatontown NJ  07724-2274
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Desmoglein 3 synthetic peptide (PI-0824)
	Trade Name:
	Orphan Designation:
	Treatment of pemphigus vulgaris
	Designation 
	10/26/2004	Sponsor and Address
	Marketing Exclusivity 	Peptimmune, Inc.
	64 Sidney Street
	Cambridge MA  02139-4170
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Desmopressin acetate	Treatment of patients with hemophilia A or von Willebrand's disease (type I)
	 whose factor VIII coagulant activity level is greater than 5%.
	Trade Name:
	Orphan Designation:
	Treatment of mild hemophilia A and von Willebrand's disease.
	Designation 
	1/22/1991	Sponsor and Address
	Marketing Exclusivity 	Aventis Behring L.L.C.
	3/7/1994	1020 First Avenue
	PO Box 61501
	King of Prussia PA  19406-0901
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dexamethasone
	Trade Name:
	Posurdex	Orphan Designation:
	For use in posterior segment drug delivery system in the treatment of 
	idiopathic intermediate uveitis.
	Designation 
	9/11/1998	Sponsor and Address
	Marketing Exclusivity 	Allergan
	2525 Dupont Drive
	P. O. Box 19534
	Irvine CA  92623-9534
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	dexanabinol
	Trade Name:
	Orphan Designation:
	For the attenuation or amelioration of the long-term neurological sequelae 
	associated with moderate and severe traumatic brain injury
	Designation 
	8/11/2004	Sponsor and Address
	Marketing Exclusivity 	Pharmos Corporation
	99 Wood Avenue
	Suite 311
	Iselin NJ  08830 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	dexrazoxane	Treatment of extravasation resulting from IV anthracycline chemotherapy
	Trade Name:
	Totect	Orphan Designation:
	Treatment of anthracycline extravasation during chemotherapy
	Designation 
	3/25/2004	Sponsor and Address
	Marketing Exclusivity 	Topo Target A/S
	9/6/2007	Fruebjergvej 3, 2100 
	Copenhagen    
	 
	DENMARK
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dexrazoxane	Cardiomyopathy associated with doxorubicin administration in women with 
	metastatic breast cancer who have received a cumulative dose of 
	300mg/m2.
	Trade Name:
	Zinecard	Orphan Designation:
	For the prevention of cardiomyopathy associated with doxorubicin 
	administration.
	Designation 
	12/17/1991	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	5/26/1995	7000 Portage Road
	Kalamazoo MI  49001-0199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	dextran 1
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	3/21/2003	Sponsor and Address
	Marketing Exclusivity 	BCY LifeSciences Inc.
	160 Eglinton Ave. East
	Suite 600
	Toronto, Ontario   M4P 3B    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dextran 70
	Trade Name:
	Dehydrex	Orphan Designation:
	Treatment of recurrent corneal erosion unresponsive to conventional 
	therapy.
	Designation 
	3/5/1990	Sponsor and Address
	Marketing Exclusivity 	Holles Laboratories, Inc.
	30 Forest Notch
	Cohasset MA  02025 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dextran and deferoxamine
	Trade Name:
	Bio-Rescue	Orphan Designation:
	Treatment of acute iron poisoning.
	Designation 
	3/8/1991	Sponsor and Address
	Marketing Exclusivity 	Biomedical Frontiers, Inc.
	1095 10th Avenue S.E.
	Minneapolis MN  55414 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Dextran sulfate (inhaled, aerosolized)
	Trade Name:
	Uendex	Orphan Designation:
	For use as an adjunct to the treatment of cystic fibrosis.
	Designation 
	10/5/1990	Sponsor and Address
	Marketing Exclusivity 	Kennedy & Hoidal, M.D.'s
	University Of Utah Medical Center
	50 North Medical Drive, Room 4R240
	Salt Lake City UT  84132 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dextran sulfate sodium
	Trade Name:
	Orphan Designation:
	Treatment of aquired immunodeficiency syndrome.
	Designation 
	11/19/1987	Sponsor and Address
	Marketing Exclusivity 	Ueno Fine Chemicals Industry, Ltd.
	2-31 Koraibashi, Higashi-ku
	Osaka 541    
	 
	JAPAN
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	DHA-paclitaxel
	Trade Name:
	Taxoprexin	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	9/25/2001	Sponsor and Address
	Marketing Exclusivity 	Luitpold Pharmaceuticals, Inc..
	1000 Madison Ave.
	Norristown PA  19403 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	DHA-paclitaxel
	Trade Name:
	Taxoprexin	Orphan Designation:
	Treatment of adenocarcinoma of the stomach or lower esophagus
	Designation 
	5/1/2003	Sponsor and Address
	Marketing Exclusivity 	Luitpold Pharmaceuticals, Inc.
	1000 Madison Ave.
	Norristown PA  19403 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	DHA-paclitaxel
	Trade Name:
	Taxoprexin	Orphan Designation:
	Treatment of metastatic malignant melanoma
	Designation 
	10/10/2002	Sponsor and Address
	Marketing Exclusivity 	Luitpold Pharmaceuticals, Inc..
	1000 Madison Ave.
	Norristown PA  19403 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Dianeal peritoneal dialysis solution with 1.1% amino 
	acids
	Trade Name:
	Nutrineal (Peritoneal Dialysis Solution with 1.1% 	Orphan Designation:
	Amino Acid
	For use as a nutritional supplement for the treatment of malnourishment in 
	patients undergoing continuous ambulatory peritoneal dialysis.
	Designation 
	6/11/1992	Sponsor and Address
	Marketing Exclusivity 	Baxter Healthcare Corporation
	1620 Waukegan Road
	McGaw Park IL  60085 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Diazepam viscous solution for rectal administration
	Trade Name:
	Orphan Designation:
	For the management of selected, refractory, patients with epilepsy, on 
	stable regimens of antiepileptic drugs (AEDs), who require intermittent use 
	Designation 	of diazepam to control bouts of increased seizure activity.
	2/25/1992	Sponsor and Address
	Marketing Exclusivity 	Valeant Pharmaceuticals
	7/29/1997	3300 Hyland Avenue
	Costa Mesa CA  92626 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Diaziquone
	Trade Name:
	Orphan Designation:
	Treatment of primary brain malignancies (grade III and IV astrocytomas).
	Designation 
	11/10/1983	Sponsor and Address
	Marketing Exclusivity 	Warner-Lambert Company
	2800 Plymouth Rd., P.O. Box 1047
	Ann Arbor MI  48106 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dideoxyinosine
	Trade Name:
	Orphan Designation:
	Treatment of acquired immunodeficiency syndrome.
	Designation 
	6/22/1988	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb
	2400 West Lloyd Expressway
	Evansville IN  47721 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Diethyldithiocarbamate
	Trade Name:
	Imuthiol	Orphan Designation:
	Treatment of AIDS.
	Designation 
	4/3/1986	Sponsor and Address
	Marketing Exclusivity 	Connaught Laboratories
	Route 611, P.O. Box 187
	Swiftwater PA  18370 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	diethylenetriaminepentaacetate (DPTA)
	Trade Name:
	Orphan Designation:
	For treatment of patients with known or suspected internal contamination 
	with plutonium, americium or curium to increase the rates of elimination.
	Designation 
	4/14/2004	Sponsor and Address
	Marketing Exclusivity 	CIS-US
	10 DeAngelo Drive
	Bedford MA  01730 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Diethylenetriaminepentaacetic acid (DTPA)	Treatment of internal contamination with plutonium, americium or curium
	Trade Name:
	Orphan Designation:
	Treatment of patients with known or suspected internal contamination with 
	plutonium, americium, or curium to increase the rates of elimination.
	Designation 
	4/28/2004	Sponsor and Address
	Marketing Exclusivity 	Hameln Pharmaceuticals gmbh
	8/11/2004	Langes Feld 13
	Hameln    
	 
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Diethylnorspermine (DENSPM)
	Trade Name:
	Orphan Designation:
	Treatment for hepatocellular carcinoma
	Designation 
	5/25/2004	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	153 Second Avenue
	Waltham MA  02451 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	diferuloylmethane
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	6/13/2003	Sponsor and Address
	Marketing Exclusivity 	Allertein Therapeutics, LLC
	640 Sasco Hill Road
	Fairfield CT  06824 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Digitoxin
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	5/27/2005	Sponsor and Address
	Marketing Exclusivity 	Bette S. Pollard, LLC
	11008 Lamplighter Lane
	Potomac MD  20854 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	digitoxin
	Trade Name:
	Orphan Designation:
	Treatment of soft tissue sarcomas
	Designation 
	10/18/2001	Sponsor and Address
	Marketing Exclusivity 	PrimeCyte, Inc.
	130 Fifth Ave., N.
	Seattle WA  98109-4933
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	digitoxin
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer
	Designation 
	11/2/2001	Sponsor and Address
	Marketing Exclusivity 	PrimeCyte, Inc.
	130 Fifth Ave., N.
	Seattle WA  98109-4933
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Digoxin immune FAB (Ovine)
	Trade Name:
	Digibind	Orphan Designation:
	Treatment of potentially life threatening digitalis intoxication in patients 
	who are refractory to management by conventional therapy.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	4/22/1986	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Digoxin immune fab(ovine)
	Trade Name:
	Digidote	Orphan Designation:
	Treatment of life-threatening acute cardiac glycoside intoxication 
	manifested by conduction disorders, ectopic ventricular activity and (in 
	Designation 	some cases) hyperkalemia.
	3/11/1985	Sponsor and Address
	Marketing Exclusivity 	Boehringer Mannheim Corp.
	1301 Piccard Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	dihydroartemisinin and piperaquine
	Trade Name:
	Eurartesim	Orphan Designation:
	Treatment of uncomplicated malaria caused by "Plasmodium falciparum," 
	Plasmodium vivax," Plasmodium malariae," or "Plasmodium ovale."
	Designation 
	1/8/2007	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	800 South Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Dihydrotestosterone
	Trade Name:
	Androgel -DHT	Orphan Designation:
	Treatment of weight loss in AIDS patients with HIV-associated wasting.
	Designation 
	2/5/1996	Sponsor and Address
	Marketing Exclusivity 	Besins Internaitonal, US Inc.
	610 Herndon Parkway
	Suite 750
	Herndon VA  20170 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	dimethyl sulfoxide
	Trade Name:
	Orphan Designation:
	For use in combination with antimicrobial drugs for the treatment of drug 
	resistant tuberculosis
	Designation 
	5/9/2008	Sponsor and Address
	Marketing Exclusivity 	Abela Pharmaceuticals, Inc.
	21581 Midcrest Drive
	Lake Forest CA  92630 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dimethyl sulfoxide
	Trade Name:
	Orphan Designation:
	Treatment of increased intracranial pressure in patients with severe, closed-
	head injury, also known as traumatic brain coma, for whom no other 
	Designation 	effective treatment is available.
	11/22/1994	Sponsor and Address
	Marketing Exclusivity 	Abela Pharmaceuticals, Inc.
	21581 Midcrest Drive
	Lake Forest CA  92630 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dimethyl sulfoxide
	Trade Name:
	Orphan Designation:
	Treatment of cutaneous manifestations of scleroderma.
	Designation 
	6/6/1986	Sponsor and Address
	Marketing Exclusivity 	Research Industries Corp.

	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dimethylsulfoxide
	Trade Name:
	Orphan Designation:
	Treatment of palmar-plantar erythrodysethesia syndrome. 
	Designation 
	4/6/1998	Sponsor and Address
	Marketing Exclusivity 	Cancer Technologies, Inc.
	7301 East 22nd Street
	Suite 10E
	Tucson AZ  85710 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Dimethylsulfoxide
	Trade Name:
	Orphan Designation:
	Topical treatment for the prevention of soft tissue injury following 
	extravastion of cytotoxic drugs. 
	Designation 
	4/15/1997	Sponsor and Address
	Marketing Exclusivity 	Cancer Technologies, Inc.
	7301 East 22nd Street
	Suite 10E
	Tucson AZ  85710 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dipalmitoylphosphatidylcholine 
	/phosphatidylglycerol
	Trade Name:
	ALEC	Orphan Designation:
	Prevention and treatment of neonatal respiratory distress syndrome.
	Designation 
	7/28/1988	Sponsor and Address
	Marketing Exclusivity 	Forum Products, Inc.
	33 Flying Point Road
	Southampton NY  11968 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	diphenylcyclopenone
	Trade Name:
	Orphan Designation:
	Treatment of chronic severe forms of alopecia areata (Alopecia Totalis 
	[AT]/Alopecia Universalis [AU])
	Designation 
	6/13/2003	Sponsor and Address
	Marketing Exclusivity 	Lloyd E. King, Jr.
	1900 Patterson Street
	Suite 104
	Nashville TN  37203 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Disaccharide tripeptide glycerol dipalmitoyl
	Trade Name:
	Immther	Orphan Designation:
	Treatment of pulmonary and hepatic metastases in patients with colorectal 
	adenocarcinoma.
	Designation 
	3/1/1990	Sponsor and Address
	Marketing Exclusivity 	ImmunoTherapeutics, Inc.
	3505 Riverview Circle
	Moorhead MN  56560 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Disodium clodronate
	Trade Name:
	Orphan Designation:
	Treatment of hypercalcemia of malignancy.
	Designation 
	6/16/1993	Sponsor and Address
	Marketing Exclusivity 	Discovery Experimental & Development, Inc.
	29949 S.R. 54 West
	Wesley Chapel FL  33543 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Disodium clodronate tetrahydrate
	Trade Name:
	Bonefos	Orphan Designation:
	Treatment of increased bone resorption due to malignancy.
	Designation 
	3/5/1990	Sponsor and Address
	Marketing Exclusivity 	Anthra Pharmaceuticals, Inc.
	103 Carnegie Center, Suite 102
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Disodium silibinin dihemisuccinate
	Trade Name:
	Legalon	Orphan Designation:
	Treatment of hepatic intoxication by Amanita phalloides (mushroom 
	poisoning).
	Designation 
	7/10/1986	Sponsor and Address
	Marketing Exclusivity 	Pharmaquest Corporation
	4470 Redwood Highway
	San Rafael CA  94903 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	DMP 777
	Trade Name:
	Orphan Designation:
	Therapeutic management of patients with lung disease attributable to 
	cystic fibrosis.
	Designation 
	6/4/1996	Sponsor and Address
	Marketing Exclusivity 	DuPont Pharmaceuticals Company
	Chestnut Run, Maple Run
	Centre Rd.
	Wilmington DE  19805 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	DNA plasmid vector expressing human IL-12 gene
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	4/4/2005	Sponsor and Address
	Marketing Exclusivity 	Expression Genetics, Inc.
	2215 Mock Road
	Huntsville AL  35801 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	DNA-lipid complex (DMRIE/DOPE)/plasmid vector 
	(VCL-1102, Vical) expressing human interleukin-2
	Trade Name:
	Leuvectin	Orphan Designation:
	Treatment of renal cell carcinoma.
	Designation 
	4/28/2000	Sponsor and Address
	Marketing Exclusivity 	Vical Incorporated
	9373 Towne Center Dr.
	Suite 100
	San Diego CA  92121-3088
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	DNP-Modified autologous tumor vaccine
	Trade Name:
	O-Vax	Orphan Designation:
	Adjuvant therapy for the treatment of ovarian cancer
	Designation 
	9/21/2000	Sponsor and Address
	Marketing Exclusivity 	AVAX Technologies, Inc.
	9200 Indian Creek Parkway
	Building 9, Suite 200
	Overland Park KS  66210 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	docosahexanoic acid-paclitaxel
	Trade Name:
	Taxoprexin	Orphan Designation:
	Treatment of hormone-refractory prostate cancer.
	Designation 
	3/5/2001	Sponsor and Address
	Marketing Exclusivity 	Luitpold Pharmaceuticals, Inc.
	1000 Madison Ave
	Norristown PA  19403 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Doripenem
	Trade Name:
	Orphan Designation:
	Treatment of bronchopulmonary infection in patients with cystic fibrosis who
	 are colonized with Pseudomonas aeruginosa or Burkholderia cepacia.
	Designation 
	7/16/2004	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical Research & Dev.
	920 US Highway 202
	P. O. Box 300
	Raritan NJ  08869 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dornase alfa	In conjunction with standard therapies in the management of cystic fibrosis 
	patients to reduce the frequency of respiratory infections requiring 
	parenteral antibiotics and to improve pulmonary function.
	Trade Name:
	Pulmozyme	Orphan Designation:
	To reduce mucous viscosity and enable the clearance of airway secretions 
	in patients with cystic fibrosis.
	Designation 
	1/16/1991	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	12/30/1993	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dovitinib
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	10/3/2006	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Doxorubicin HCL liposome injection	For use in combination with bortezomib for the treatment of patients with 
	multiple myeloma who have not previously received bortezomib and have 
	at least one prior
	Trade Name:	therapy.
	Doxil	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	12/29/2004	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical Research & Dev.
	5/17/2007	920 US Highway 202, P. O. Box 300
	Raritan NJ  08869 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Doxorubicin HCl with pluronic L-61 and pluronic F-127
	Trade Name:
	Orphan Designation:
	Treatment of esophageal carcinoma
	Designation 
	10/7/2005	Sponsor and Address
	Marketing Exclusivity 	Supratek Pharma Inc.
	215Bouchard Blvd
	Dorval
	Quebec H9S 1A9    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Doxorubicin liposome	Treatment of metastatic carcinoma of the ovary in patients with disease that
	 is refractory to both paclitaxel- and platinium-based chemotherapy 
	regimens.  Refractory disease is defined as disease that has progressed 
	Trade Name:	while on treatment, or within 6 months of completing treatment.  
	Doxil	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	11/4/1998	Sponsor and Address
	Marketing Exclusivity 	Alza Corporation
	6/28/1999	1550 Plymouth St.
	PO Box 7210
	Mountain View CA  94039-7210
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	doxorubicin PIHCA nanoparticles
	Trade Name:
	Doxorubicin Transdrug	Orphan Designation:
	Treatment of hepatocellular carcinoma
	Designation 
	3/14/2005	Sponsor and Address
	Marketing Exclusivity 	BioAlliance Pharma
	59, Bd Gal Martial Valin - 75015
	Paris    
	 
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	doxorubicin with pluronics F-127 and L-61 
	Trade Name:
	Orphan Designation:
	Treatment of gastric cancer
	Designation 
	2/20/2008	Sponsor and Address
	Marketing Exclusivity 	Supratek Pharma, Inc.
	215 Bouchard Blvd
	Dorval, Quebec H9S 1A9
	    
	CANADA
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	D-peptide of the sequence AKRHHGYKRKFH - NH2
	Trade Name:
	PulmaDex	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	10/23/2002	Sponsor and Address
	Marketing Exclusivity 	Demegen, Inc.
	100 Technology Drive
	Suite 440 B
	Pittsburgh PA  15219 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dronabinol	Treatment of anorexia associated with weight loss in patients with AIDS.
	Trade Name:
	Marinol	Orphan Designation:
	For the stimulation of appetite and prevention of weight loss in patients 
	with a confirmed diagnosis of AIDS.
	Designation 
	1/15/1991	Sponsor and Address
	Marketing Exclusivity 	Unimed Pharmaceuticals, Inc.
	12/22/1992	901 Sawyer Rd.
	Marietta  GA  30062 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Droxidopa
	Trade Name:
	Orphan Designation:
	Treatment of neurogenic symptomatic orthostatic hypotension in patients 
	with primary autonomic failure, dopamine-beta-hydroxylase deficiency, and
	Designation 	 nondiabetic autonomic neuropathy.
	1/17/2007	Sponsor and Address
	Marketing Exclusivity 	Chelsea Therapeutics, Inc.
	13950 Ballantyne Corporate Place
	Charlotte NC  28277 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Duramycin
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	12/11/1997	Sponsor and Address
	Marketing Exclusivity 	Lantibio, Inc.
	100 Europa Drive
	Suite 421
	Chapel Hill NC  27517 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dynamine
	Trade Name:
	Orphan Designation:
	Treatment of hereditary motor and sensory neuropathy type I (Charcot-
	Marie-Tooth disease).
	Designation 
	10/16/1991	Sponsor and Address
	Marketing Exclusivity 	Mayo Foundation
	200 First Street Southwest
	Rochester MN  55905 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Dynamine
	Trade Name:
	Orphan Designation:
	Treatment of Lambert Eaton myasthenic syndrome.
	Designation 
	2/5/1990	Sponsor and Address
	Marketing Exclusivity 	Mayo Foundation
	200 First Street Southwest
	Rochester MN  55905 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	eculizumab
	Trade Name:
	Orphan Designation:
	Idiopathic membranous glomerular nephropathy
	Designation 
	3/5/2001	Sponsor and Address
	Marketing Exclusivity 	Alexion Pharmaceuticals, Inc.
	352 Knotter Drive
	Cheshire CT  06410 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	eculizumab	Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis
	Trade Name:
	Soliris	Orphan Designation:
	Treatment of paroxysmal nocturnal hemoglobinuria
	Designation 
	8/20/2003	Sponsor and Address
	Marketing Exclusivity 	Alexion Pharmaceuticals, Inc.
	3/16/2007	352 Knotter Drive
	Cheshire CT  06410 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Edotreotide
	Trade Name:
	OctreoTher	Orphan Designation:
	Treatment of somatostatin receptor-positive neuroendocrine 
	gastroenteropancreatic tumors
	Designation 
	7/28/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corp.
	59 Route 10/Bldg 122/N142
	One Health Plaza
	East Hanover NJ  07936-1080
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Efaproxiral
	Trade Name:
	Orphan Designation:
	Adjunct to whole brain radiation therapy for the treatment of brain 
	metastases in patients with breast cancer
	Designation 
	7/28/2004	Sponsor and Address
	Marketing Exclusivity 	Allos Therapeutics, Inc.
	11080 CirclePoint Road
	Suite 200
	Westminster CO  80020 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Eflornithine
	Trade Name:
	Orphan Designation:
	Treatment of anaplastic glioma
	Designation 
	9/29/2006	Sponsor and Address
	Marketing Exclusivity 	VBL Pharmaceuticals, Inc.
	216 Robin Way
	Menlo Park CA  94025 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Eflornithine  HCl
	Trade Name:
	Ornidyl	Orphan Designation:
	Treatment of Pneumocystis carinii pneumonia in AIDS patients.
	Designation 
	4/18/1986	Sponsor and Address
	Marketing Exclusivity 	Marion Merrell Dow, Inc.
	P.O. Box 9627
	Kansas City MO  64134 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Eflornithine HCl
	Trade Name:
	Ornidyl	Orphan Designation:
	Treatment of Trypanosoma brucei gambiense infection (sleeping sickness).
	Designation 
	4/23/1986	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel
	11/28/1990	P.O. Box 9627
	Kansas City MO  64134 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Elcatonin
	Trade Name:
	Orphan Designation:
	Intrathecal treatment of intractable pain.
	Designation 
	9/25/1995	Sponsor and Address
	Marketing Exclusivity 	Innapharma, Inc.
	10 Mountainview Road
	Upper Saddle River NJ  07458 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	eltrombopag 
	Trade Name:
	Promacta	Orphan Designation:
	Treatment of idiopathic thrombocytopenia purpura
	Designation 
	5/5/2008	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline
	1250 South Collegeville Road
	UP 4110
	Collegeville  PA  19426 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Enadoline hydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of severe head injury.
	Designation 
	1/28/1997	Sponsor and Address
	Marketing Exclusivity 	Warner-Lambert Company
	Parke-Davis Pharmaceutical Research Division
	2800 Plymouth Road
	Ann Arbor MI  48105 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Encapsulated porcine islet preparation
	Trade Name:
	BetaRx	Orphan Designation:
	Treatment of type I diabetic patients who are already on 
	immunosuppression.
	Designation 
	7/5/1995	Sponsor and Address
	Marketing Exclusivity 	VivoRx
	2825 Santa Monica Blvd.
	2nd Floor
	Santa Monica CA  90404-2429
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	eniluracil 
	Trade Name:
	Orphan Designation:
	Treatment of hepatocellular carcinoma 
	Designation 
	12/15/2005	Sponsor and Address
	Marketing Exclusivity 	Adherex Technologies, Inc.
	4620 Creekstone Drive
	Research Triangle Park 
	Durham NC  27703 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Enisoprost
	Trade Name:
	Orphan Designation:
	For use in organ transplant patients to diminish the nephrotoxicity induced 
	by cyclosporine.
	Designation 
	10/20/1989	Sponsor and Address
	Marketing Exclusivity 	G.D. Searle & Company
	4901 Searle Parkway
	Skokie IL  60077 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Enisoprost
	Trade Name:
	Orphan Designation:
	For use with cyclosporine in organ transplant recipients to reduce acute 
	transplant rejection.
	Designation 
	10/20/1989	Sponsor and Address
	Marketing Exclusivity 	G.D. Searle & Company
	4901 Searle Parkway
	Skokie IL  60077 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Enteric-coated cysteamine
	Trade Name:
	Orphan Designation:
	Treatment of cystinosis
	Designation 
	10/24/2006	Sponsor and Address
	Marketing Exclusivity 	Univ of Cal. San Diego Medical Center, Hillcrest
	Div. of Gastroenterology, Hepathology, Nutrition
	200 West Arbor Drive
	San Diego CA  92103-8450
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Enzastaurin
	Trade Name:
	Orphan Designation:
	Treatment of glioblastoma multiforme
	Designation 
	9/19/2005	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly and Company
	Lilly Corporate Center
	Indianapolis IN  46285 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epidermal growth factor (human)
	Trade Name:
	Orphan Designation:
	For acceleration of corneal epithelial regeneration and the healing of 
	stromal tissue in the condition of non-healing corneal defects.
	Designation 
	10/5/1987	Sponsor and Address
	Marketing Exclusivity 	Chiron Vision
	500 Iolab Drive
	Claremont CA  91711 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epidermal growth factor (human)
	Trade Name:
	Orphan Designation:
	For promotion of cutaneous wound healing in extreme burn treatment 
	protocols.
	Designation 
	3/6/1985	Sponsor and Address
	Marketing Exclusivity 	Ethicon, Inc.
	P.O. Box 151
	Somerville NJ  08876 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epirubicin	Component of adjuvant therapy in patients with evidence of axillary node 
	tumor involvement following resection of primary breast cancer.
	Trade Name:
	Ellence	Orphan Designation:
	Treatment of breast cancer.
	Designation 
	9/14/1999	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn Company
	9/15/1999	0634-298-113
	7000 Portage Rd.
	Kalamazoo MI  49001-0199
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Epoetin alfa	Treatment of AZT-induced anemia in HIV infected patients.
	Trade Name:
	Epogen	Orphan Designation:
	Treatment of anemia associated with HIV infection or HIV treatment.
	Designation 
	7/1/1991	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	12/31/1990	1840 Dehavilland Drive
	Thousand Oaks CA  91320 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epoetin alfa
	Trade Name:
	Epogen	Orphan Designation:
	Treatment of anemia associated with end stage renal disease.
	Designation 
	4/10/1986	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	6/1/1989	1840 Dehavilland Drive
	Thousand Oaks CA  91320 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epoetin alfa
	Trade Name:
	Orphan Designation:
	Treatment of myelodysplastic syndrome.
	Designation 
	12/20/1993	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical Research & Dev., 
	920 U.S. Highway
	Route 202, P.O. Box 300
	Raritan NJ  08869-0602
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epoetin alpha
	Trade Name:
	Procrit	Orphan Designation:
	Treatment of anemia associated with end stage renal disease.
	Designation 
	8/27/1987	Sponsor and Address
	Marketing Exclusivity 	R. W. Johnson Pharmaceutical Research Institute
	Route 202 South
	P.O. Box 300
	Raritan NJ  08869 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epoetin alpha
	Trade Name:
	Procrit	Orphan Designation:
	Treatment of anemia of prematurity in preterm infants.
	Designation 
	7/21/1988	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical R & D, LLC
	920 US Highway 202 
	P.O. Box 300
	Raritan NJ  08869-0602
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Epoetin alpha
	Trade Name:
	Procrit	Orphan Designation:
	Treatment of HIV associated anemia related to HIV infection or HIV 
	treatment.
	Designation 
	3/7/1989	Sponsor and Address
	Marketing Exclusivity 	R. W. Johnson Pharmaceutical Research Institute
	Route 202, P.O. Box 300
	Raritan NJ  08869 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epoetin beta
	Trade Name:
	Marogen	Orphan Designation:
	Treatment of anemia associated with end stage renal disease.
	Designation 
	10/22/1987	Sponsor and Address
	Marketing Exclusivity 	Chugai-USA, Inc.
	3780 Hawthorn Court
	Waukegan IL  60087 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epoprostenol	For the long-term intravenous treatment of pulmonary hypertension 
	associated with the scleroderma spectrum of disease in New York Heart 
	Association (NYHA) Class III and Class IV patients who do not respond 
	Trade Name:	adequately to conventional therapy.
	Flolan	Orphan Designation:
	Treatment of secondary pulmonary hypertension due to intrinsic 
	precapillary pulmonary vascular disease.  
	Designation 
	3/22/1999	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline
	4/14/2000	Five Moore Dr.
	PO Box 13398
	Research Triangle Park NC  27709-3398
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epoprostenol	Long-term intravenous treatment of primary pulmonary hypertension in 
	NYHA Class III and Class IV patients.
	Trade Name:
	Flolan	Orphan Designation:
	Treatment of primary pulmonary hypertension.
	Designation 
	9/25/1985	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	9/20/1995	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epoprostenol
	Trade Name:
	Flolan	Orphan Designation:
	Replacement of heparin in patients requiring hemodialysis and who are at 
	increased risk of hemorrhage.
	Designation 
	3/29/1984	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Epoprostenol
	Trade Name:
	Cycloprostin	Orphan Designation:
	Replacement of heparin in patients requiring hemodialysis and who are at 
	increased risk of hemorrhage.
	Designation 
	10/29/1984	Sponsor and Address
	Marketing Exclusivity 	Upjohn Company
	301 Henrietta Street
	Kalamazoo MI  49001 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	epratuzumab
	Trade Name:
	LymphoCIDE	Orphan Designation:
	Treatment of non-Hodgkin's lymphoma.  
	Designation 
	7/13/1998	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Eprodisate
	Trade Name:
	Fibrillex	Orphan Designation:
	Treatment of secondary amyloidosis
	Designation 
	4/6/1999	Sponsor and Address
	Marketing Exclusivity 	Neurochem, Inc.
	7220 Frederick Banting, Suite 100
	Saint-Laurent
	Quebec H4S 2A1    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epstein Barr Virus specific cytotoxic T lymphocytes
	Trade Name:
	Orphan Designation:
	Prevention and treatment of EBV-post transplant lymphoproliferative 
	disease after hematopoietic stem cell transplant or solid organ transplant.
	Designation 
	12/27/2006	Sponsor and Address
	Marketing Exclusivity 	Center for Cell and Gene Therapy
	Feigin Center
	Suite 1120
	Houston TX  77030-2399
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Erlotinib Hydrochloride
	Trade Name:
	Tarceva	Orphan Designation:
	Treatment of malignant gliomas
	Designation 
	7/18/2003	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc
	1 DNA Way
	South San Francisco CA  94080-4990
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Erwinia L-asparaginase
	Trade Name:
	Erwinase	Orphan Designation:
	Treatment of acute lymphocytic leukemia.
	Designation 
	7/30/1986	Sponsor and Address
	Marketing Exclusivity 	EUSA  Pharma (US), Inc.
	1980 South Easton Road
	Suite 250
	Doylestown PA  18901 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Erwinia L-asparaginase
	Trade Name:
	Orphan Designation:
	For use as an alternative to E. coli asparaginase in those situations where 
	repeat courses of asparaginase therapy for acute lymphoblastic leukemia 
	Designation 	are required or where allergic reactions force the discontinuance of the E. 
	1/25/1985	Sponsor and Address	coli preparation.
	Marketing Exclusivity 	Lyphomed, Inc.

	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Erythropoietin (human, recombinant)
	Trade Name:
	Orphan Designation:
	Treatment of anemia associated with end stage renal disease.
	Designation 
	11/19/1987	Sponsor and Address
	Marketing Exclusivity 	Organon Teknika Corporation

	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Erythropoietin (recombinant human)
	Trade Name:
	Orphan Designation:
	Treatment of anemia associated with end stage renal disease.
	Designation 
	8/19/1987	Sponsor and Address
	Marketing Exclusivity 	McDonnell Douglas Corp
	P.O. Box 516, 107/2  MS10
	St. Louis MO  63166 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Estradiol Gel
	Trade Name:
	EstroGel	Orphan Designation:
	Estrogen replacement therapy in females with Turner syndrome
	Designation 
	10/31/2006	Sponsor and Address
	Marketing Exclusivity 	Ascend Therapeutics, Inc.
	607 Herndon Parkway
	Herndon VA  21070 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Etanercept
	Trade Name:
	Enbrel	Orphan Designation:
	Treatment of Wegener's granulomatosis.  
	Designation 
	4/6/1999	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	51 University Street
	Seattle WA  98101-2936
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	etanercept	Reduction in signs and symptoms of moderately to severely active 
	polyarticular-course juvenile rheumatoid arthritis in patients who have had 
	an inadequate response to one or more disease-modifying anti-rheumatic 
	Trade Name:	drugs.
	Enbrel	Orphan Designation:
	Reduction in signs and symptoms of moderately to severely active 
	polyarticular-course juvenile rheumatoid arthritis in patients who have had 
	Designation 	an inadequate response to one or more disease-modifying anti-rheumatic 
	10/27/1998	Sponsor and Address	drugs.
	Marketing Exclusivity 	Immunex Corporation
	5/27/1999	51 University St.
	Seattle WA  98101-2936
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ethanol gel 
	Trade Name:
	Orphan Designation:
	Treatment of congenital lymphatic malformations
	Designation 
	3/13/2006	Sponsor and Address
	Marketing Exclusivity 	Orfagen
	Parc Technologique du Canal
	31521 Ramonville Saint Agne Cedex
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ethanol gel
	Trade Name:
	Orphan Designation:
	Treatment of congenital venous malformations
	Designation 
	3/29/2006	Sponsor and Address
	Marketing Exclusivity 	Orfagen
	Parc Technologique du Canal
	31521 Ramonville Saint Agne Cedex
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ethanolamine oleate
	Trade Name:
	Ethamolin	Orphan Designation:
	Treatment of patients with esophageal varices that have recently bled, to 
	prevent rebleeding.
	Designation 
	3/22/1984	Sponsor and Address
	Marketing Exclusivity 	Block Drug Company, Inc.
	12/22/1988	257 Cornelison Avenue
	Jersey City NJ  07302 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Ethinyl Estradiol, USP
	Trade Name:
	Orphan Designation:
	Treatment of Turner's syndrome.
	Designation 
	6/22/1988	Sponsor and Address
	Marketing Exclusivity 	Bio-Technology General Corp.
	70 Wood Avenue, South
	Iselin NJ  08830 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ethiofos
	Trade Name:
	Orphan Designation:
	Use as a chemoprotective agent for cisplatin and cyclophosphamide in the 
	treatment of ovarian cancer.
	Designation 
	8/1/1989	Sponsor and Address
	Marketing Exclusivity 	U.S. Bioscience
	100 Front Street
	West Conshohocken PA  19428 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ethyl eicosapentaenoate
	Trade Name:
	Orphan Designation:
	Treatment of Huntington's disease.
	Designation 
	4/6/2000	Sponsor and Address
	Marketing Exclusivity 	Laxdale Ltd.
	Kings Park House, Laurelhill Business Park
	Polmaise Road, Stirling FK7 9JQ
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Etidronate disodium
	Trade Name:
	Didronel IV infusion	Orphan Designation:
	Prevention of degenerative metabolic bone disease occurring in patients 
	who require long term (6 months or greater) total parenteral nutrition.
	Designation 
	5/2/1991	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma, Inc.
	6300 West Old Shakoppe Rd.
	Suite 110
	Bloomington MN  55438-2318
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Etidronate disodium
	Trade Name:
	Didronel IV Infusion	Orphan Designation:
	Treatment of degenerative metabolic bone disease occurring in patients 
	who require long term (6 months or greater) total parenteral nutrition.
	Designation 
	5/2/1991	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma, Inc.
	6300 West Old Shakoppe Rd.
	Suite 110
	Bloomington MN  55438-2318
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Etidronate disodium
	Trade Name:
	Didronel	Orphan Designation:
	Treatment of hypercalcemia of malignancy inadequately managed by 
	dietary modification and/or oral hydration.
	Designation 
	3/21/1986	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma, Inc.
	4/21/1987	5775 West Old Shakoppe Rd.
	Suite 100
	Bloomington MN  55437-3107
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Etiocholanedione
	Trade Name:
	Orphan Designation:
	Treatment of Prader-Willi syndrome.
	Designation 
	5/7/1996	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	Two Annabel Lane, Suite 220
	San Ramon CA  94583 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Etiocholanedione
	Trade Name:
	Orphan Designation:
	Treatment of aplastic anemia.
	Designation 
	11/3/1995	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	Two Annabel Lane, Suite 220
	Suite 10
	San Ramon CA  94583 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	everolimus
	Trade Name:
	Orphan Designation:
	Treatment of gastroenteropancreatic neuroendocrine tumors
	Designation 
	2/14/2008	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ex vivo cultured adult human mesenchymal stem 
	cells
	Trade Name:
	Prochymal	Orphan Designation:
	Treatment of acute graft versus host disease
	Designation 
	12/14/2005	Sponsor and Address
	Marketing Exclusivity 	Osiris Therpeutics, Inc.
	2001 Aliceanna Street
	Baltimore MD  21231-3043
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Exemestane	Treatment of advanced breast cancer in postmenopausal women whose 
	disease has progressed following tamoxifen therapy.
	Trade Name:
	Aromasin	Orphan Designation:
	Treatment of advanced breast cancer in postmenopausal women whose 
	disease has progressed following tamoxifen therapy.
	Designation 
	9/19/1991	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	10/21/1999	7000 Portage Road
	Mail Stop:  0636-298-113
	Kalamazoo MI  49001-0199
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Exisulind
	Trade Name:
	Orphan Designation:
	For the suppression and control of colonic adenomatous polyps in the 
	inherited disease adenomatous polyposis coli.
	Designation 
	2/14/1994	Sponsor and Address
	Marketing Exclusivity 	OSI Pharmaceuticals, Inc.
	58 South Service Road
	Suite 110
	Melville NY  11747 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Factor XIII [A2] homodimer, recombinant DNA origin
	Trade Name:
	Orphan Designation:
	Treatment of congenital FXIII deficiency
	Designation 
	5/21/2003	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk Pharmaceuticals, INc.
	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Factor XIII [A2} homodimer, recombinant DNA origin
	Trade Name:
	Orphan Designation:
	For the prophylaxis of bleeding associated with congential FXIII deficiency
	Designation 
	11/6/2003	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	factor XIII concentrate (human), pasteurized
	Trade Name:
	Fibrogammin P	Orphan Designation:
	Treatment of congenital factor XIII deficiency.
	Designation 
	1/16/1985	Sponsor and Address
	Marketing Exclusivity 	CSL Behring L.L.C.
	1020 First Ave.
	PO Box 61501
	King of Prussia PA  19406-0901
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Factor XIII, recombinant
	Trade Name:
	Orphan Designation:
	Treatment of congenital factor XIII deficiency.
	Designation 
	4/22/1993	Sponsor and Address
	Marketing Exclusivity 	Zymogenetics, Inc.
	4225 Roosevelt Way
	Seattle WA  98105 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fampridine
	Trade Name:
	Neurelan	Orphan Designation:
	Treatment of chronic, incomplete spinal cord injury. 
	Designation 
	6/2/1997	Sponsor and Address
	Marketing Exclusivity 	Acorda Therapeutics, Inc.
	15 Skyline Dr.
	Hawthorne NY  10532 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fampridine
	Trade Name:
	Neurelan	Orphan Designation:
	Relief of symptoms of multiple sclerosis.
	Designation 
	6/2/1987	Sponsor and Address
	Marketing Exclusivity 	Acorda Therapeutics
	15 Skyline Dr.
	Hawthorne NY  10532 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Felbamate	As adjunctive therapy in the treatment of partial and generalized seizures 
	associated with the Lennox-Gastaut syndrome in children.
	Trade Name:
	Felbatol	Orphan Designation:
	Treatment of Lennox-Gastaut syndrome.
	Designation 
	1/24/1989	Sponsor and Address
	Marketing Exclusivity 	Wallace Laboratories
	7/29/1993	301B College Road East
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fenobam hydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of fragile X syndrome
	Designation 
	11/20/2006	Sponsor and Address
	Marketing Exclusivity 	Neuropharm, Ltd.
	Fetcham Park House
	Leatherhead, Surrey  KT22 9HD
	    
	UNITED KINGDOM
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	fenretinide
	Trade Name:
	Orphan Designation:
	Treatment of Ewing's sarcoma family of tumors.
	Designation 
	2/1/2007	Sponsor and Address
	Marketing Exclusivity 	Cancer Research UK
	61 Lincoln's Inn Fields
	London WC2A 3PX
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fenretinide
	Trade Name:
	Orphan Designation:
	Treatment of neuroblastoma
	Designation 
	10/5/2005	Sponsor and Address
	Marketing Exclusivity 	USC-CHLA Institute for Pediatric Clinical Research
	Childrens Hospital Los Angeles
	4650 Sunset Blve, MS 55
	Los Angeles CA  90027 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ferric hexacyanoferrate (II) "Prussian Blue"
	Trade Name:
	Orphan Designation:
	Treatment of patients with known or suspected internal contamination with 
	radioactive or non-radioactive cesium or thallium
	Designation 
	6/26/2003	Sponsor and Address
	Marketing Exclusivity 	Degussa AG
	Weissfrauenstr.9
	D-60287 
	Frankfurt    
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	FIAU
	Trade Name:
	Orphan Designation:
	Adjunctive treatment of chronic active hepatitis B.
	Designation 
	7/24/1992	Sponsor and Address
	Marketing Exclusivity 	Oclassen Pharmaceuticals, Inc.
	100 Pelican Way
	San Rafael CA  94901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fibrinogen (human)
	Trade Name:
	Orphan Designation:
	For the control of bleeding and prophylactic treatment of patients deficient 
	in fibrinogen.
	Designation 
	8/23/1995	Sponsor and Address
	Marketing Exclusivity 	Alpha Therapeutic Corporation
	5555 Valley Boulevard
	Los Angeles CA  90032 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Fibronectin (human plasma derived)
	Trade Name:
	Orphan Designation:
	Treatment of non-healing corneal ulcers or epithelial defects which have 
	been unresponsive to conventional therapy and the underlying cause has 
	Designation 	been eliminated.
	9/5/1988	Sponsor and Address
	Marketing Exclusivity 	Melville Biologics, Inc.
	310 East 67th Street
	New York NY  10021 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fibronectin (plasma derived)
	Trade Name:
	Orphan Designation:
	Treatment of non-healing corneal ulcers or epithelial defects which are 
	unresponsive to conventional therapy and for which any infectious cause of 
	Designation 	the defect has been eliminated.
	12/5/1988	Sponsor and Address
	Marketing Exclusivity 	Chiron Vision
	9342 Jeronimo Road
	Irvine CA  92718 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Filgrastim	Treatment of patients with severe chronic neutropenia.
	Trade Name:
	Neupogen	Orphan Designation:
	Treatment of patients with severe chronic neutropenia (absolute neutrophil 
	count less than 500/mm3).
	Designation 
	11/7/1990	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	12/19/1994	1840 Dehavilland Drive
	Thousand Oaks CA  91320 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Filgrastim
	Trade Name:
	Neupogen	Orphan Designation:
	Treatment of myelodysplastic syndrome.
	Designation 
	8/30/1990	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	1840 Dehavilland Drive
	Thousand Oaks CA  91320 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Filgrastim	Reduce the duration of neutropenia and neutropenia sequelae in patients 
	with non-myeloid malignancies undergoing ablative chemotherapy 
	followed by BMT.
	Trade Name:
	Neupogen	Orphan Designation:
	Treatment of neutropenia associated with bone marrow transplants.
	Designation 
	10/1/1990	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	6/15/1994	1840 Dehavilland Drive
	Thousand Oaks CA  91320 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Filgrastim	Reducing the time to neutrophil recovery and the duration of fever, 
	following induction or consolidation chemotherapy treatment of adults with 
	acute myeloid leukemia.
	Trade Name:
	Neupogen	Orphan Designation:
	Reduction in the duration of neutropenia, fever, antibiotic use, and 
	hospitalization, following induction and consolidation treatment for acute 
	Designation 	myeloid leukemia.
	11/7/1996	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	4/2/1998	One Amgen Center Dr.
	Thousand Oaks CA  91320-1799
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Filgrastim
	Trade Name:
	Neupogen	Orphan Designation:
	Treatment of patients with AIDS who, in addition, are afflicted with 
	cytomegalovirus retinitis and are being treated with ganciclovir.
	Designation 
	9/3/1991	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	One Amgen Center Dr.
	Thousand Oaks CA  91320-1799
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Filgrastim	For use in the mobilization of hematopoietic progenitor cells into the 
	peripheral blood collection by leukapheresis.
	Trade Name:
	Neupogen	Orphan Designation:
	For use in the mobilization of peripheral blood progenitor cells for 
	collection in patients who will receive myeloablative or myelosuppressive 
	Designation 	chemotherapy.
	7/17/1995	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	12/28/1995	1840 Dehavilland Drive
	Thousand Oaks CA  91320 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Floxuridine, FUDR
	Trade Name:
	Orphan Designation:
	Intraperitoneal treatment of gastric cancer. 
	Designation 
	12/22/2004	Sponsor and Address
	Marketing Exclusivity 	Franco Muggia, M.D.
	160 East 34th Street
	New York NY  10016 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fludarabine phosphate
	Trade Name:
	Fludara	Orphan Designation:
	Treatment of chronic lymphocytic leukemia (CLL), including refractory CLL.
	Designation 
	4/18/1989	Sponsor and Address
	Marketing Exclusivity 	Berlex Laboratories, Inc.
	4/18/1991	15049 San Pablo Avenue, P.O. Box 4099
	Richmond CA  94804 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Fludarabine phosphate
	Trade Name:
	Fludara	Orphan Designation:
	Treatment and management of patients with non-Hodgkins lymphoma.
	Designation 
	4/18/1989	Sponsor and Address
	Marketing Exclusivity 	Berlex Laboratories, Inc.
	15049 San Pablo Avenue
	P.O. Box 4099
	Richmond CA  94804-0099
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fludarabine phosphate oral tablets	Major contribution to patient care. IV to oral
	Trade Name:
	Orphan Designation:
	Treatment of B-cell chronic lymphocytic leukemia
	Designation 
	12/18/2007	Sponsor and Address
	Marketing Exclusivity 	Xanthus Pharmaceuticals, Inc.
	300 Technology Square
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Flumecinol
	Trade Name:
	Zixoryn	Orphan Designation:
	Treatment of hyperbilirubinemia in newborn infants unresponsive to 
	phototherapy.
	Designation 
	1/15/1985	Sponsor and Address
	Marketing Exclusivity 	Farmacon, Inc.
	Post House, Suite 213
	1720 Post Road East
	Westport CT  06880-5643
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Flunarizine
	Trade Name:
	Sibelium	Orphan Designation:
	Treatment of alternating hemiplegia.
	Designation 
	1/6/1986	Sponsor and Address
	Marketing Exclusivity 	Janssen Research Foundation
	P.O. Box 200
	Titusville NJ  08560 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fluocinolone	Treatment of chronic non-infectious uveitis affecting the posterior segment 
	of the eye
	Trade Name:
	Retisert	Orphan Designation:
	Treatment uveitis involving the posterior segment of the eye.
	Designation 
	7/31/2000	Sponsor and Address
	Marketing Exclusivity 	Bausch & Lomb Pharmaceuticals, Inc.
	4/8/2005	8500 Hidden River Parkway
	Tampa FL  33637 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Fluorouracil
	Trade Name:
	Adrucil	Orphan Designation:
	For use in combination with leucovorin for therapy of metastatic 
	adenocarcinoma of the colon and rectum.
	Designation 
	2/6/1989	Sponsor and Address
	Marketing Exclusivity 	Lederle Laboratories
	Division of American Cyanamid Company
	401 N. Middletown Road
	Pearl River NY  10965 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fluorouracil
	Trade Name:
	Orphan Designation:
	For use in combination with interferon alpha-2a, recombinant, for the 
	treatment of esophageal carcinoma.
	Designation 
	10/27/1989	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110-1199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fluorouracil
	Trade Name:
	Orphan Designation:
	For use in combination with interferon alpha-2a, recombinant, for the 
	treatment of advanced colorectal carcinoma.
	Designation 
	4/18/1990	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110-1199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fluorouracil
	Trade Name:
	Orphan Designation:
	Treatment of glioblastoma multiforme.
	Designation 
	6/29/2000	Sponsor and Address
	Marketing Exclusivity 	Ethypharm SA
	194 Bureaux de la Colline - Batiment D
	92213 Saint-Cloud Cedex
	    
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fluoxetine
	Trade Name:
	Prozac	Orphan Designation:
	Treatment of autism.
	Designation 
	4/30/1999	Sponsor and Address
	Marketing Exclusivity 	Neuropharm, Ltd.
	Felcham Park House
	Lower Road, Leatherhead
	    
	UNITED KINGDOM
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Fluoxetine
	Trade Name:
	Prozac	Orphan Designation:
	Treatment of body dysmorphic disorder in children and adolescents
	Designation 
	4/14/2004	Sponsor and Address
	Marketing Exclusivity 	Hollander, Eric MD
	The Mount Sinai School of Medicine
	One Gustave L. Levy Place
	New York NY  10029-6574
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Follitropin alfa, recombinant	For the induction of spermatogenesis in men with primary and secondary 
	hypogonadotropic hypogonadism in whom the cause of infertility is not due
	 to primary testicular failure.
	Trade Name:
	Gonal-F	Orphan Designation:
	For the initiation and re-initiation of spermatogenesis in adult males with 
	reproductive failure due to hypothalamic or pituitary dysfunction, 
	Designation 	hypogonadotropic hypogonadism.  AMENDED indication 6/27/00:  For the 
	12/21/1998	induction of spermatogenesis in men with primary and secondary 
	hypogonadotropic hypogonadism in whom the cause of infertility is not due
	 to primary testicular failure.
	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	5/24/2000	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fomepizole	Use for suspected or confirmed methanol poisoning, either alone or in 
	combination with hemodialysis
	Trade Name:
	Antizole	Orphan Designation:
	Treatment of methanol or ethylene glycol poisoning.
	Designation 
	12/22/1988	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals
	12/8/2000	3180 Porter Drive
	Palo Alto  CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fomepizole	As an antidote to ethylene glycol (antifreeze) poisoning, or for use in 
	suspected ethylene glycol ingestion.
	Trade Name:
	Antizole	Orphan Designation:
	Treatment of methanol or ethylene glycol poisoning.
	Designation 
	12/22/1988	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals
	12/4/1997	3180 Porter Drive
	Palo Alto  CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fosphenytoin	For the control of generalized convulsive status epilepticus.
	Trade Name:
	Cerebyx	Orphan Designation:
	For the acute treatment of patients with status epilepticus of the grand mal 
	type.
	Designation 
	6/4/1991	Sponsor and Address
	Marketing Exclusivity 	Warner-Lambert Company
	8/5/1996	2800 Plymouth Road
	Ann Arbor MI  48106 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Fructose-1,6-diphosphate
	Trade Name:
	Cordox	Orphan Designation:
	Treatment of painful vaso-occlusive episodes associated with sickle cell 
	disease.
	Designation 
	5/29/1998	Sponsor and Address
	Marketing Exclusivity 	Questcor Pharmaceuticals, Inc.
	3260 Whipple Road
	Union City CA  94587-1217
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fully Human Anti-MCP-1/CCL2 Monoclonal Antibody
	Trade Name:
	Orphan Designation:
	Treatment of idiopathic pulmonary fibrosis.
	Designation 
	11/8/2007	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Vallley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fusion protein consisting of human immunoglobim 
	G1 constant region Fc region fused to the human 
	receptor binding domain of ectodysplasin-A1
	Trade Name:
	Orphan Designation:
	Treatment of X-linked hypohidrotic ectodermal dysplasia
	Designation 
	1/11/2006	Sponsor and Address
	Marketing Exclusivity 	Apoxis SA
	Av de Sevelin, 18-20
	Lausanne, Switzerland    
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	G17DT Immunogen
	Trade Name:
	Orphan Designation:
	Treatment of gastric cancer
	Designation 
	7/18/2002	Sponsor and Address
	Marketing Exclusivity 	Receptor BioLogix, Inc.
	1140 Veterans Blvd.
	Suite A
	South San Francisco CA  94080 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	G17DT Immunogen
	Trade Name:
	Orphan Designation:
	Treatment of adenocarcinoma of the pancreas
	Designation 
	7/10/2002	Sponsor and Address
	Marketing Exclusivity 	Receptor BioLogix, Inc.
	1140 Veterans Blvd.
	Suite A
	South San Francisco CA  94080 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Gabapentin
	Trade Name:
	Neurontin	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis.
	Designation 
	7/5/1995	Sponsor and Address
	Marketing Exclusivity 	Warner-Lambert Company
	Parke-Davis Pharmaceutical Research Division
	2800 Plymouth Road
	Ann Arbor MI  48105 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gallium nitrate injection
	Trade Name:
	Ganite	Orphan Designation:
	Treatment of hypercalcemia of malignancy.
	Designation 
	12/5/1988	Sponsor and Address
	Marketing Exclusivity 	Solopak Pharmaceutical Co.
	1/17/1991	1845 Tonne Road
	Elk Grove Village IL  60007 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gamma hydroxybutyrate
	Trade Name:
	Orphan Designation:
	Treatment of narcolepsy and the auxiliary symptoms of cataplexy, sleep 
	paralysis, hypnagogic hallucinations and automatic behavior.
	Designation 
	12/3/1987	Sponsor and Address
	Marketing Exclusivity 	Biocraft Laboratories, Inc.
	18-01 River Road
	Fair Lawn NJ  07410 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gamma-hydroxybutyric acid
	Trade Name:
	Orphan Designation:
	Treatment of narcolepsy and the auxiliary symptoms of cataplexy, sleep 
	paralysis, hypnagogic hallucinations, and automatic behavior.
	Designation 
	1/22/1985	Sponsor and Address
	Marketing Exclusivity 	Sigma Chemical Company

	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gammalinolenic acid
	Trade Name:
	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis.
	Designation 
	7/27/1994	Sponsor and Address
	Marketing Exclusivity 	Zurier, Robert B. M.D.
	University of Massachusetts Medical Center
	55 Lake Avenue
	Worcester MA  01655 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Ganaxolone
	Trade Name:
	Orphan Designation:
	Treatment of infantile spasms.
	Designation 
	5/25/1994	Sponsor and Address
	Marketing Exclusivity 	Marinus Pharmaceuticals, Inc.
	21 Business Park Drive
	Branford CT  06405 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ganciclovir
	Trade Name:
	Virgan	Orphan Designation:
	Treatment of acute herpetic keratitis (dendritic and geographic ulcers)
	Designation 
	3/22/2007	Sponsor and Address
	Marketing Exclusivity 	Sirion Therapeutics, Inc.
	3110 Cherry Palm Drive
	Tampa  FL  33619 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ganciclovir intravitreal implant	Treatment of CMV retinitis in patients with acquired immunodeficiency 
	syndrome.
	Trade Name:
	Vitrasert Implant	Orphan Designation:
	Treatment of cytomegalovirus retinitis.
	Designation 
	6/7/1995	Sponsor and Address
	Marketing Exclusivity 	Bausch & Lomb Surgical, Chiron Vision Products
	3/4/1996	9342 Jeronimo Road
	Irvine CA  92718-1903
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ganciclovir sodium
	Trade Name:
	Cytovene	Orphan Designation:
	Treatment of cytomegalovirus retinitis in immunocompromised patients 
	with AIDS.
	Designation 
	10/31/1985	Sponsor and Address
	Marketing Exclusivity 	Syntex (USA), Inc.
	6/23/1989	3401 Hillview Avenue
	Palo Alto CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gancyclovir
	Trade Name:
	Orphan Designation:
	Treatment of severe human cytomegalovirus infections in specific 
	immunosuppressed patient populations.
	Designation 
	6/7/1985	Sponsor and Address
	Marketing Exclusivity 	Burroughs Wellcome Company
	3030 Cornwallis Road
	P.O. Box 12700
	Research Triangle Park NC  27709 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Gangliosides as sodium salts
	Trade Name:
	Cronassial	Orphan Designation:
	Treatment of retinitis pigmentosa.
	Designation 
	11/17/1988	Sponsor and Address
	Marketing Exclusivity 	Fidia Pharmaceutical Corp.
	1401 Eye Street, N.W. Suite 900
	Washington DC  20005 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gavilimomab
	Trade Name:
	Orphan Designation:
	Acute graft-versus-host disease (aGVHD)
	Designation 
	11/20/2000	Sponsor and Address
	Marketing Exclusivity 	Amgen
	One Amgen Center Drive
	Mail Stop 17-2-A
	Thousand Oaks CA  91320-1799
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gemtuzumab zogamicin	Treatment of patients with CD33 positive acute myeloid leukemia in first 
	relapse who are 60 years of age or older and who are not considered 
	candidates for cytotoxic chemotherapy
	Trade Name:
	Mylotarg	Orphan Designation:
	Treatment of CD33-positive acute myeloid leukemia.
	Designation 
	11/24/1999	Sponsor and Address
	Marketing Exclusivity 	Wyeth-Ayerst Laboratories
	5/17/2000	PO Box 8299
	Philadelphia PA  19101-8299
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gene plasmid hVEGF165 driven by human 
	cytomegalovirus, and [2,3-bis(oleoyl)propyl]trimethyl 
	ammonium and dioleoyl phosphatidyl ethanolamine
	Trade Name:
	Trinam	Orphan Designation:
	Prevention of complications due to neointimal hyperplasia disease in 
	certain vascular anastomoses.
	Designation 
	10/24/2000	Sponsor and Address
	Marketing Exclusivity 	Ark Therapeutics Ltd.
	1 Fitzroy  Mews
	London W1T6DE
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	genetically engineered herpes simplex virus (G207)
	Trade Name:
	Orphan Designation:
	Tretament of malignant glioma
	Designation 
	4/29/2002	Sponsor and Address
	Marketing Exclusivity 	MediGene, Inc.
	10660 Scripps Ranch Blvd.
	Suite 200
	San Diego CA  92131 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Geneticin
	Trade Name:
	Orphan Designation:
	Treatment of amoebiasis.
	Designation 
	6/6/2005	Sponsor and Address
	Marketing Exclusivity 	ProcesScience, Inc (PSI)
	505 Irving Avenue
	Syracuse NY  13210 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gentamicin impregnated PMMA beads on surgical 
	wire
	Trade Name:
	Septopal	Orphan Designation:
	Treatment of chronic osteomyelitis of post-traumatic, postoperative, or 
	hematogenous origin.
	Designation 
	1/31/1991	Sponsor and Address
	Marketing Exclusivity 	Lipha Pharmaceuticals, Inc.
	9 West 57th Street
	Suite 3825
	New York NY  10019-2701
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gentamicin liposome injection
	Trade Name:
	Maitec	Orphan Designation:
	Treatment of disseminated Mycobacterium avium-intracellulare infection.
	Designation 
	7/10/1990	Sponsor and Address
	Marketing Exclusivity 	Liposome Company, Inc.
	One Research Way
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	glatiramer acetate
	Trade Name:
	Copaxone	Orphan Designation:
	Treatment of amyothrophic lateral sclerosis (ALS).
	Designation 
	11/14/2007	Sponsor and Address
	Marketing Exclusivity 	Teva Neurosciences, Inc.
	P. O. Box 1005
	Horsham PA  19044-8005
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Glatiramer acetate	For reduction of the frequency of relapses in patients with relapsing-
	remitting multiple sclerosis.
	Trade Name:
	Copaxone	Orphan Designation:
	Treatment of multiple sclerosis.
	Designation 
	11/9/1987	Sponsor and Address
	Marketing Exclusivity 	Teva Pharmaceuticals USA
	12/20/1996	1510 Delp Drive
	Kulpsville PA  19443 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Glatiramer acetate for injection
	Trade Name:
	Copaxone	Orphan Designation:
	Treatment of primary-progressive multiple sclerosis
	Designation 
	6/5/2001	Sponsor and Address
	Marketing Exclusivity 	TEVA Pharmaceuticals, USA
	1090 Horsham Road
	North Wales PA  19454 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	glucarpidase
	Trade Name:
	Voraxaze	Orphan Designation:
	Treatment of patients at risk of methotrexate toxicity
	Designation 
	8/19/2003	Sponsor and Address
	Marketing Exclusivity 	Protherics, Inc.
	5214 Maryland Way, Suite 405
	Brentwood TN  37027 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	glufosfamide
	Trade Name:
	Orphan Designation:
	For treatment of pancreatic cancer.
	Designation 
	9/18/2006	Sponsor and Address
	Marketing Exclusivity 	Threshold Pharmaceuticals, Inc.
	1300 Seaport Blvd.
	Redwood City CA  94063 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Glutamine	Treatment of short bowel syndrome in patients receiving specialized 
	nutritional support when used in conjunction with a rercombinant human 
	growth hormone that is approved for this indication.
	Trade Name:
	NutreStore	Orphan Designation:
	For use with human growth hormone in the treatment of short bowel 
	syndrome (nutrient malabsorption from the gastrointestinal tract resulting 
	Designation 	from an inadequate absorptive surface).
	3/6/1995	Sponsor and Address
	Marketing Exclusivity 	Nutritional Restart Pharmaceutical, L.P.
	6/10/2004	4364 South Alston Avenue
	Durham NC  27713 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Glyceol
	Trade Name:
	Orphan Designation:
	To decrease intracranial hypertension and/or alleviate cerebral edema in 
	patients who may benefit from osmotherapy.
	Designation 
	2/22/1990	Sponsor and Address
	Marketing Exclusivity 	Chugai Pharmaceutical Co., Ltd.

	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Glyceryl tri (4-phenylbutyrate)
	Trade Name:
	Orphan Designation:
	Treatment of spinal muscular atrophy
	Designation 
	5/24/2005	Sponsor and Address
	Marketing Exclusivity 	Ucyclyd Pharma, Inc
	Subsidiary of Medicis Pharmaceutical Corporation
	Scottsdale AZ  85258 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Glyceryl trioleate and glyceryl trierucate
	Trade Name:
	Orphan Designation:
	Treatment of adrenoleukodystrophy.
	Designation 
	2/14/1995	Sponsor and Address
	Marketing Exclusivity 	Moser, Hugo W. M.D.
	Johns Hopkins University
	Kennedy Krieger Institute, 707 North Broadway
	Baltimore MD  21205 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Glycopyrrolate 
	Trade Name:
	Orphan Designation:
	Treatment of pathologic (chronic moderate to severe) drooling in pediatric 
	patients
	Designation 
	6/9/2006	Sponsor and Address
	Marketing Exclusivity 	Sciele Pharma, Inc.
	Five Concourse Parkway
	Suite 1800
	Atlanta GA  30328 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Golimumab
	Trade Name:
	Orphan Designation:
	Treatment of chronic sarcoidosis
	Designation 
	11/2/2004	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gonadorelin acetate
	Trade Name:
	Lutrepulse	Orphan Designation:
	For induction of ovulation in women with hypothalamic amenorrhea due to 
	a deficiency or absence in the quantity or pulse pattern of endogenous 
	Designation 	GnRH secretion.
	4/22/1987	Sponsor and Address
	Marketing Exclusivity 	Ferring Laboratories, Inc.
	10/10/1989	400 Rella Boulevard, Suite 201
	Suffern NY  10901 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Gossypol
	Trade Name:
	Orphan Designation:
	Treatment of cancer of the adrenal cortex.
	Designation 
	10/22/1990	Sponsor and Address
	Marketing Exclusivity 	Reidenberg, Marcus M. M.D.
	The New York Hospital - Cornell Medical Center
	525 East 68th Street, Box 70
	New York NY  10021 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gp100 adenoviral gene therapy
	Trade Name:
	Orphan Designation:
	Treatment of metastatic melanoma.
	Designation 
	3/25/1997	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	500 Kendall Street
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Granulocyte macrophage-colony stimulating factor
	Trade Name:
	Leucomax	Orphan Designation:
	Treatment of severe thermal injuries in patients with greater than 40% full 
	or partial thickness burns.
	Designation 
	6/6/1989	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Granulocyte macrophage-colony stimulating factor
	Trade Name:
	Leucomax	Orphan Designation:
	Treatment of chronic lymphocytic leukemia to increase granulocyte count.
	Designation 
	5/4/1990	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Granulocyte macrophage-colony stimulating factor
	Trade Name:
	Leucomax	Orphan Designation:
	Treatment of myelodysplastic syndrome.
	Designation 
	8/7/1989	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Granulocyte macrophage-colony stimulating factor
	Trade Name:
	Leucomax	Orphan Designation:
	Treatment of neutropenia associated with bone marrow transplants.
	Designation 
	12/12/1989	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Granulocyte macrophage-colony stimulating factor
	Trade Name:
	Leucomax	Orphan Designation:
	Treatment of neutropenia due to hairy cell leukemia.
	Designation 
	5/3/1990	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Group B streptococcus immune globulin
	Trade Name:
	Orphan Designation:
	Treatment of neonates for disseminated group B streptococcal infection.
	Designation 
	5/8/1990	Sponsor and Address
	Marketing Exclusivity 	North American Biologicals, Inc.
	12280 Wilkins Avenue
	Rockville MD  20852 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Growth hormone releasing factor
	Trade Name:
	Orphan Designation:
	For the long-term treatment of children who have growth failure due to a 
	lack of adequate endogenous growth hormone secretion.
	Designation 
	8/7/1989	Sponsor and Address
	Marketing Exclusivity 	Valeant Pharmaceuticals International
	One Enterprise Way
	Aliso Viejo CA  92656 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Guanethidine monosulfate
	Trade Name:
	Ismelin	Orphan Designation:
	Treatment of moderate to severe reflex sympathetic dystrophy and 
	causalgia.
	Designation 
	1/6/1986	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Guanfacine
	Trade Name:
	Tenex	Orphan Designation:
	Treatment of fragile X syndrome.
	Designation 
	8/5/1999	Sponsor and Address
	Marketing Exclusivity 	Watson Laboratories, Inc.
	311 Bonnie Circle
	PO Box 1900
	Corona CA  91718-1900
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gusperimus
	Trade Name:
	Spanidin	Orphan Designation:
	Treatment of acute renal graft rejection episodes.
	Designation 
	6/27/1996	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	5 Research Parkway
	P.O.  Box 5100
	Wallingford CT  06492-7660
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	h5G1.1-mAb
	Trade Name:
	Orphan Designation:
	Treatment of dermatomyositis
	Designation 
	9/21/2000	Sponsor and Address
	Marketing Exclusivity 	Alexion Pharmaceuticals, Inc.
	352 Knotter Drive
	Cheshire CT  06410 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Halofantrine	Treatment of adults who can tolerate oral medication and who have mild to
	 moderate malaria caused by Plasmodium falciparum or Plasmodium 
	vivax.
	Trade Name:
	Halfan	Orphan Designation:
	Treatment of mild to moderate acute malaria caused by susceptible strains 
	of P. falciparum and P. vivax.
	Designation 
	11/4/1991	Sponsor and Address
	Marketing Exclusivity 	SmithKline Beecham Pharmaceuticals
	7/24/1992	One Franklin Plaza
	P.O. Box 7929
	Philadelphia PA  19101 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Halofuginone
	Trade Name:
	Stenorol	Orphan Designation:
	Treatment of systemic sclerosis.
	Designation 
	2/7/2000	Sponsor and Address
	Marketing Exclusivity 	Collgard Biopharmaceuticals Ltd.
	Textile House, 2 Koifman St.
	Tel-Aviv 68012
	    
	ISRAEL
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	heat killed Mycobacterium w immunomodulator
	Trade Name:
	CADI Mw	Orphan Designation:
	Active tuberculosis
	Designation 
	9/3/2004	Sponsor and Address
	Marketing Exclusivity 	Cadila Pharmaceuticals Limited, Inc.
	9801 Washingtonian Blvd
	Suite 220
	Gaithersburg MD  20878 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	heat killed mycobacterium w immunomodulator
	Trade Name:
	CADI Mw	Orphan Designation:
	Adjuvant to multi-drug therapy in the management of multibacillary leprosy
	Designation 
	11/21/2002	Sponsor and Address
	Marketing Exclusivity 	CPL, Inc.
	16020 Swingley Ridge Road
	Suite 145
	Chesterfield MO  63017 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Heme arginate
	Trade Name:
	Normosang	Orphan Designation:
	Treatment of symptomatic stage of acute porphyria.
	Designation 
	3/10/1988	Sponsor and Address
	Marketing Exclusivity 	Orphan Europe
	Immeuble Le Guillaumet
	92046 Paris La Defense
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Heme arginate
	Trade Name:
	Normosang	Orphan Designation:
	Treatment of myelodysplastic syndromes.
	Designation 
	3/1/1994	Sponsor and Address
	Marketing Exclusivity 	Orphan Europe
	Immeuble Le Guillaumet
	70 avenue du General de Gaulle,
	92056 Paris La Defense    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hemin
	Trade Name:
	Panhematin	Orphan Designation:
	Amelioration of recurrent attacks of acute intermittent porphyria (AIP) 
	temporarily related to the menstrual cycle in susceptible women and similar
	Designation 	 symptoms which occur in other patients with AIP, porphyria variegata and 
	3/16/1984	hereditary coproporphyria.
	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	7/20/1983	Diagnostics Division
	Abbott Park IL  60064 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Hemin and zinc mesoporphyrin
	Trade Name:
	Hemex	Orphan Designation:
	Treatment of acute porphyric syndromes.
	Designation 
	12/20/1993	Sponsor and Address
	Marketing Exclusivity 	Bonkovsky, Herbert L. M.D.
	University Of Massachusetts Medical Center
	55 Lake Avenue North
	Worcester MA  01655 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hemoximer (pyridoxalated hemoglobin 
	polyoxyethylene)
	Trade Name:
	Orphan Designation:
	Treatment of cardiogenic shock
	Designation 
	12/18/2007	Sponsor and Address
	Marketing Exclusivity 	Apex Bioscience, Inc.
	109 Conner Drive
	`
	Chapel Hill NC  27514 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Heparin
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	11/3/2005	Sponsor and Address
	Marketing Exclusivity 	Vectura Group, Inc.
	1 Prospect West
	Wiltshire SN14 6FH
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Heparin sodium
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	6/29/2006	Sponsor and Address
	Marketing Exclusivity 	Ockham Biotech Limited
	Manor Farm
	98 Swanwick Lane
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Heparin-binding epidermal growth factor-like growth 
	factor
	Trade Name:
	Orphan Designation:
	Prevention and treatment of necrotizing enterocolitis (NEC) in preterm 
	infants with birth weight less than 1,500 grams
	Designation 
	9/18/2006	Sponsor and Address
	Marketing Exclusivity 	Trillium Therapeutics, Inc.
	96 Skyway Avenue
	M9W 4Y4
	    
	CANADA
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	hepatitis B immune globulin (human)	Prevention of hepatitis B recurrence following liver transplantation in 
	HBsAG-positive liver transplant patients
	Trade Name:
	HepaGam	Orphan Designation:
	Prevention of hepatitis B recurrence following orthotopic liver transplant
	Designation 
	3/24/2008	Sponsor and Address
	Marketing Exclusivity 	Cangene Corporation
	4/6/2007	155 Innovation Drive

	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hepatitis B immune globulin intravenous (human)
	Trade Name:
	Nabi-HB	Orphan Designation:
	Prophylaxis against hepatitis B virus reinfection in liver transplant patients.
	Designation 
	3/8/1995	Sponsor and Address
	Marketing Exclusivity 	Biotest Pharmaceuticals Corporation
	5800 Park of Commerce Blvd., NW
	Boca Raton FL  33487 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hepatitis C virus immune globulin (human)
	Trade Name:
	Orphan Designation:
	Prophylaxis of hepatitis C infection in liver transplant recipients.
	Designation 
	11/14/2002	Sponsor and Address
	Marketing Exclusivity 	Biotest Pharmaceuticals Corporation
	5800 Park of Commerce Blvd, NW
	Boca Raton FL  33487 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	HepeX-B
	Trade Name:
	Orphan Designation:
	For the prevention of hepatitis B virus (HBV) reinfection in patients who 
	have received a liver transplantation
	Designation 
	7/15/2003	Sponsor and Address
	Marketing Exclusivity 	Cubist Pharmaceuticals
	65 Hayden Avnue
	Lexington MA  02421 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Herpes simplex virus gene
	Trade Name:
	Orphan Designation:
	Treatment of primary and metastatic brain tumors.
	Designation 
	10/16/1992	Sponsor and Address
	Marketing Exclusivity 	Genetic Therapy, Inc.
	938 Clopper Road
	Gaithersburg MD  20878 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Histamine
	Trade Name:
	Maxamine	Orphan Designation:
	For use as an adjunct to cytokine therapy in the treatment of malignant 
	melanoma.
	Designation 
	2/1/2000	Sponsor and Address
	Marketing Exclusivity 	EpiCept Corporation
	777 Old Saw Mill River Road
	Tarrytown NY  10591 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Histamine
	Trade Name:
	Ceplene	Orphan Designation:
	Adjunct to cytokine therapy in the treatment of acute myeloid leukemia.
	Designation 
	12/15/1999	Sponsor and Address
	Marketing Exclusivity 	EpiCept Corporation
	777 Old Saw Mill River Road
	Tarrytown NY  10591 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Histrelin 	Treatment of central precocious puberty
	Trade Name:
	Supprelin LA	Orphan Designation:
	Treatment of central precocious puberty
	Designation 
	11/18/2005	Sponsor and Address
	Marketing Exclusivity 	Indevus Pharmaceuticals (Formerly Valera Pharma.) 
	5/3/2007	33 Hayden Avenue
	Lexington MA  02421 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Histrelin
	Trade Name:
	Orphan Designation:
	Treatment of acute intermittent porphyria, hereditary coproporphyria, and 
	variegate porphyria.
	Designation 
	5/3/1991	Sponsor and Address
	Marketing Exclusivity 	Anderson, Karl E., M.D.
	University of Texas Medical Branch at Galveston
	Route J-09,  700 The Strand
	Galveston TX  77550 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Histrelin acetate	Treatment of central precocious puberty.
	Trade Name:
	Supprelin Injection	Orphan Designation:
	Treatment of central precocious puberty.
	Designation 
	8/10/1988	Sponsor and Address
	Marketing Exclusivity 	Roberts Pharmaceutical Corp.
	12/24/1991	Meridian Center III
	6 Industrial Way West
	Eatontown NJ  07724 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	HIV neutralizing antibodies
	Trade Name:
	Immupath	Orphan Designation:
	Treatment of acquired immunodeficiency syndrome.
	Designation 
	3/24/1992	Sponsor and Address
	Marketing Exclusivity 	Hemacare Corporation
	4954 Van Nuys Boulevard
	Sherman Oaks CA  91403 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	HLA-B7/Beta2M DNA Lipid (DMRIE/DOPE) Complex
	Trade Name:
	Allovectin-7	Orphan Designation:
	Treatment of invasive and metastatic melanoma (Stages II, III, and IV).  
	Designation 
	9/30/1999	Sponsor and Address
	Marketing Exclusivity 	Vical Incorporated
	9373 Towne Centre Dr., Suite 100
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	homoharringtonine
	Trade Name:
	Orphan Designation:
	Treatment for chronic myelogenous leukemia
	Designation 
	2/8/2002	Sponsor and Address
	Marketing Exclusivity 	American BioScience, Inc.
	2730 Wilshire Blvd. #110
	Santa Monica CA  90403 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	HPA-23
	Trade Name:
	Orphan Designation:
	Treatment of acquired immunodeficiency syndrome.
	Designation 
	7/17/1985	Sponsor and Address
	Marketing Exclusivity 	Rhone-Poulenc Rorer Pharm.
	500 Arcola Road
	Collegeville PA  19426 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hsp E7
	Trade Name:
	Orphan Designation:
	Treatment of recurrent respiratory papillomatosis (RRP)
	Designation 
	3/19/2001	Sponsor and Address
	Marketing Exclusivity 	StressGen Biotechnologies, Inc. is now Nventa
	Nventa Biopharmaceuticals Corporation
	6055 Lusk Boulevard
	San Diego CA  19426-2655
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Hu1D10, humanized monoclonal antibody
	Trade Name:
	Remitogen	Orphan Designation:
	For use in the treatment of 1D10+ B cell non-Hodgkin's lymphoma
	Designation 
	11/28/2001	Sponsor and Address
	Marketing Exclusivity 	PDL BioPharma, Inc.
	34801 Campus Drive
	Fremont CA  94555 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human acid precursor alpha-glucosidase, 
	recombinant
	Trade Name:
	Orphan Designation:
	Treatment of glycogen storage disease type II.
	Designation 
	9/10/1996	Sponsor and Address
	Marketing Exclusivity 	Pharming/Genzyme LLC
	c/o Genzyme Corporation
	1 Mountain Rd.
	Framingham MA  01701-9322
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human alpha 2,6 sialyltransferase adenoviral gene 
	therapy
	Trade Name:
	Orphan Designation:
	Treatment of patients with invasive (malignant) brain and central nervous 
	system tumors lacking alpha 2,6 sialyltransferase.
	Designation 
	4/4/2005	Sponsor and Address
	Marketing Exclusivity 	Falk Center for Molecular Therapeutics
	1801 Maple Avenue
	Suite 4300
	Evanston IL  60201 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human anti-CD30 monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of Hodgkin's disease
	Designation 
	9/27/2004	Sponsor and Address
	Marketing Exclusivity 	Medarex, Inc.
	519 Route 173 West
	Bloomsbury NJ  08804 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	human anti-CD4 monoclonal antibody
	Trade Name:
	HuMax-CD4	Orphan Designation:
	Treatment of mycosis fungoides
	Designation 
	8/13/2004	Sponsor and Address
	Marketing Exclusivity 	Genmab A/S
	Tolbodgade 33
	DK-1253 Copenhagen K    
	 
	DENMARK
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Human anti-integrin receptor av monoclonal 
	antibody
	Trade Name:
	Orphan Designation:
	Treatment of patients with angiosarcoma
	Designation 
	5/5/2005	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	human anti-integrin receptor avb3/avb5 monoclonal 
	antibody
	Trade Name:
	Orphan Designation:
	Treatment of patients with high-risk stage II, stage III, and stage IV 
	malignant melanoma
	Designation 
	12/1/2004	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	human anti-transforming growth factor beta 1 
	monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of systemic sclerosis
	Designation 
	1/11/2002	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	One Kendall Square
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	human anti-transforming growth factor-B1,2,3
	Trade Name:
	Orphan Designation:
	Treatment of idiopathic pulmonary fibrosis 
	Designation 
	7/9/2004	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	500 Kendall Street
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human autologous bone-forming cell derived from 
	bone marrow stem cells
	Trade Name:
	Orphan Designation:
	Treatment of osteonecrosis
	Designation 
	3/24/2008	Sponsor and Address
	Marketing Exclusivity 	Bone Therapeutics S.A.
	8, rue Adrienne Bolland

	BELGIUM
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	human coagulation factor XI 
	Trade Name:
	Hemoleven	Orphan Designation:
	Treatment of severe congential Factor XI deficiency.
	Designation 
	11/8/2007	Sponsor and Address
	Marketing Exclusivity 	Laboratoire francais du Fractionnement et des Biot
	3 Avenue des Tropiques
	91985 Courtaboeuf Cedex
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human cytomegalovirus immunoglobulin
	Trade Name:
	Orphan Designation:
	Prevention of congenital cytomegalovirus (CMV) infection following primary
	 CMV infection in pregnant women
	Designation 
	12/20/2006	Sponsor and Address
	Marketing Exclusivity 	Biotest Diagnostics Corporation
	66 Ford Road
	Denville NJ  07834 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human factor X
	Trade Name:
	Orphan Designation:
	Treatment of hereditary factor X deficiency
	Designation 
	11/8/2007	Sponsor and Address
	Marketing Exclusivity 	Bio Products Laboratory
	Dagger Lane
	Hertfordshire, WD6 3BX
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human fibrinogen concentrate, pasteurized
	Trade Name:
	Orphan Designation:
	Treatment of fibrinogen deficient patients
	Designation 
	3/13/2008	Sponsor and Address
	Marketing Exclusivity 	CSL Behring, LLC
	1020 First Avenue
	King of Prussia PA  19406 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	human gammaglobulin
	Trade Name:
	Orphan Designation:
	Treatment of gastrointestinal disturbances (to include constipation, 
	diarrhea, and abdominal pain) associated with regression-onset autism in 
	Designation 	pediatric patients.
	9/16/2002	Sponsor and Address
	Marketing Exclusivity 	Protein Therapeutics, Inc.
	70 Calle Encanto
	Tucson AZ  85716 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	human gammaglobulin
	Trade Name:
	Orphan Designation:
	Treatment of idiopathic inflammatory myopathies
	Designation 
	11/14/2003	Sponsor and Address
	Marketing Exclusivity 	Protein Therapeutics, Inc.
	70 Calle Encanto
	Tucson AZ  85716 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	human gammaglobulin
	Trade Name:
	Orphan Designation:
	Treatment for juvenile rheumatoid arthritis
	Designation 
	5/25/2001	Sponsor and Address
	Marketing Exclusivity 	Protein Therapeutics, Inc.
	70 Calle Encanto
	Tuscon  AZ  85716 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human IgM monoclonal antibody (C-58) To CMV
	Trade Name:
	Centovir	Orphan Designation:
	Prophylaxis of cytomegalovirus infections in bone marrow transplant 
	patients.
	Designation 
	8/7/1989	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	244 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human IgM monoclonal antibody (C-58) To CMV
	Trade Name:
	Centovir	Orphan Designation:
	Treatment of cytomegalovirus infections in allogenic bone marrow 
	transplant patients.
	Designation 
	8/7/1989	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	244 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human immune globulin
	Trade Name:
	Xepol	Orphan Designation:
	Treatment of post-polio syndrome
	Designation 
	3/29/2006	Sponsor and Address
	Marketing Exclusivity 	Pharmalink AB
	P. O. Box 625

	SWEDEN
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Human immunodeficiency virus immune globulin
	Trade Name:
	Orphan Designation:
	Treatment of AIDS.
	Designation 
	11/21/1989	Sponsor and Address
	Marketing Exclusivity 	NABI
	5800 Park of Commerce Blvd., NW
	Boca Raton FL  33487 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human immunodeficiency virus immune globulin
	Trade Name:
	Orphan Designation:
	Treatment of HIV-infected pregnant women and infants of HIV-infected 
	mothers.
	Designation 
	3/25/1992	Sponsor and Address
	Marketing Exclusivity 	NABI
	5800 Park of Commerce Blvd., N.W.
	Boca Raton FL  33487 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human immunodeficiency virus immune globulin
	Trade Name:
	Hivig	Orphan Designation:
	Treatment of HIV-infected pediatric patients.
	Designation 
	1/4/1995	Sponsor and Address
	Marketing Exclusivity 	NABI
	5800 Park of Commerce Blvd., NW
	Boca Raton FL  33487 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human immunoglobin anti-CD30 monoclonal 
	antibody
	Trade Name:
	Orphan Designation:
	Treatment of CD30+ T-cell lymphoma
	Designation 
	1/10/2006	Sponsor and Address
	Marketing Exclusivity 	Medarex, Inc.
	519 Route 173 West
	Bloomsbury NJ  08804 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human immunoglobulin (IgG1k)antiCTLA-4 
	monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of high risk Stage II, Stage III, and Stage IV melanoma
	Designation 
	6/3/2004	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Insti
	5 Research Parkway
	Signature 91 Bldg/3SIG-3012
	Wallingford CT  06492 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	human leukocyte-derived cytokine mixture
	Trade Name:
	Orphan Designation:
	For neoadjuvant therapy in pts. w/squamous cell carcinoma of the head 
	and neck
	Designation 
	7/7/2005	Sponsor and Address
	Marketing Exclusivity 	IRX Therapeutics, Inc.
	140 West 57th Street
	New York City NY  10019 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human monoclonal antibody against platelet-
	derived growth factor D
	Trade Name:
	Orphan Designation:
	To slow the progression of IgA nephropathy and delay kidney failure in 
	patients affected by the disease.
	Designation 
	11/2/2004	Sponsor and Address
	Marketing Exclusivity 	CuraGen Corporation
	322 East Main Street
	Branford CT  06405 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human monoclonal antibody directed against 
	serotype 011 Pseudomonas aeruginosa
	Trade Name:
	Aerumab 11	Orphan Designation:
	Treatment of hospital acquired pneumonia caused by serotype 011 positive
	 Pseudomonas aeruginosa
	Designation 
	9/18/2006	Sponsor and Address
	Marketing Exclusivity 	Kenta Biotech Limited
	Rehhagstrsase

	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human monoclonal antibody of the Ig1/k-isotype 
	against human interleukin-1 beta
	Trade Name:
	Orphan Designation:
	Treatment of cryopyrin-associated periodic syndromes
	Designation 
	12/18/2007	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human monoclonal antibody targeting CC-
	chemokine ligand 2
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	10/24/2006	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Valley PArkway
	Malvern PA  19355-1307
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Human plasma coagulation Factor VIII and human 
	plasma von Willebrand Factor
	Trade Name:
	Wilate	Orphan Designation:
	Treatment of von Willebrand disease except for surgical and/or invasive 
	procedures in patients with von Willebrand disease in whom desmopressin 
	Designation 	is either ineffective or contraindicated
	4/18/2007	Sponsor and Address
	Marketing Exclusivity 	Octapharma USA, Inc.
	121 River Street
	12th Floor
	Hoboken NJ  07030 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human prothrombin complex concentrate 
	Trade Name:
	Octaplex	Orphan Designation:
	Reversal of anticoagulation therapy in patients needing treatment of 
	serious or life threatening bleeding and/or needing urgent surgery or 
	Designation 	invasive procedures
	2/1/2008	Sponsor and Address
	Marketing Exclusivity 	Octapharma USA, Inc.
	121 River Street
	12th Floor
	Hoboken NJ  07030 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human telomerase reverse transcriptase peptide 
	vaccine
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	7/20/2006	Sponsor and Address
	Marketing Exclusivity 	Pharmexa A/S
	Koigle Alle 6

	DENMARK
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human T-lymphotropic virus type III Gp160 antigens
	Trade Name:
	Vaxsyn HIV-1	Orphan Designation:
	Treatment of AIDS.
	Designation 
	11/20/1989	Sponsor and Address
	Marketing Exclusivity 	MicroGeneSys, Inc.
	1000 Research Parkway
	Meriden CT  06450 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Human umbilical tissue-derived cells
	Trade Name:
	Orphan Designation:
	Treatment of retinitis pigmentosa
	Designation 
	3/13/2006	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc
	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Humanized anti-CD2 monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of graft-versus-host disease.
	Designation 
	11/13/1998	Sponsor and Address
	Marketing Exclusivity 	MedImmune, Inc.
	35 West Watkins Mill Rd.
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Humanized anti-CD3 monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of recent-onset Type I diabetes
	Designation 
	9/29/2006	Sponsor and Address
	Marketing Exclusivity 	MacroGenics, Inc.
	1500 East Gude Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	humanized anti-human CD16 monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of adult idiopathic thrombocytopenic purpura 
	Designation 
	3/21/2005	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	500 Kendall Street
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Humanized anti-human CD2 MAb
	Trade Name:
	MEDI-507	Orphan Designation:
	For the induction of donor-specific immunologic unresponsiveness resulting 
	in prophylaxis of organ rejection without the need for chronic 
	Designation 	immunosuppressive therapy, in patients receiving allogeneic renal 
	9/17/1998	Sponsor and Address	transplants.  
	Marketing Exclusivity 	Biotransplant, Inc.
	Building 75, 3rd. Ave.
	Charlestown Navy Yard
	Charlestown MA  02129 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Humanized anti-tac
	Trade Name:
	Zenapax	Orphan Designation:
	Prevention of acute graft-vs-host disease following bone marrow 
	transplantation.
	Designation 
	3/5/1993	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110-1199
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Humanized MAb (IDEC-131) to CD40L
	Trade Name:
	Orphan Designation:
	Treatment of systemic lupus erythematosus.
	Designation 
	2/9/1999	Sponsor and Address
	Marketing Exclusivity 	Biogen IdecInc. 
	3030 Callan Rd.
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	humanized monoclonal antibody against Shiga-like 
	toxin II
	Trade Name:
	Orphan Designation:
	To prevent the development of or to decrease the incidence and severity of
	 hemolytic uremic syndrome and associated sequelae of  Shiga-like toxin-
	Designation 	producing E. coli.
	9/12/2001	Sponsor and Address
	Marketing Exclusivity 	Teijin America, Inc.
	600 Alexander Park
	Suite 304
	Princeton NJ  08540 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Humanized monoclonal antibody to the high affinity 
	folate alpha receptor
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer
	Designation 
	6/16/2006	Sponsor and Address
	Marketing Exclusivity 	Morphotek, Inc.
	210 Welsh Pool Road
	Exton PA  19341 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	hyaluronic acid
	Trade Name:
	Orphan Designation:
	Treatment of emphysema in patients due to alpha-1 antitrypsin deficiency
	Designation 
	3/19/2002	Sponsor and Address
	Marketing Exclusivity 	CoTherix
	5000 Shoreline Court
	Suite 101
	South San Francisco CA  94080 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hydralazine
	Trade Name:
	Orphan Designation:
	Treatment of severe intrapartum hypertension (diastolic blood pressure 
	greater than or equal to 110 or systolic blood pressure greater than or equal
	Designation 	 to 160) associated with severe preeclampsia/eclampsia of pregnancy
	4/9/2004	Sponsor and Address
	Marketing Exclusivity 	Barbeau Pharma, Inc.
	790 W. Frontage Road
	Suite 125
	Northfield IL  60093 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Hydroxocobalamin	Treatment on known or suspected cyanide poisoning
	Trade Name:
	Cyanokit	Orphan Designation:
	Treatment of acute cyanide poisoning
	Designation 
	11/25/2003	Sponsor and Address
	Marketing Exclusivity 	Merck Sante, s.a.a.
	12/15/2006	37  rue Saint Romain
	69008 Lyon
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hydroxocobalamin
	Trade Name:
	Orphan Designation:
	Treatment of acute cyanide poisoning
	Designation 
	9/22/2000	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals
	3180 Porter Drive
	Palo Alto  CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hydroxycobalamin/sodium thiosulfate
	Trade Name:
	Orphan Designation:
	Treatment of severe acute cyanide poisoning.
	Designation 
	10/4/1985	Sponsor and Address
	Marketing Exclusivity 	Hall, Alan H., M.D.
	Mile 5.0 Pass Creek Road
	PO Box 24
	Elk Mountain WY  82324 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	hydroxyurea
	Trade Name:
	Orphan Designation:
	Treatment of pediatric patients with sickle cell anemia.
	Designation 
	4/15/2005	Sponsor and Address
	Marketing Exclusivity 	UPM Pharmaceuticals, Inc.
	6200 Seaforth Street
	Baltimore MD  21224 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hydroxyurea	To reduce the frequency of painful crises and to reduce the need for blood 
	transfusions in adult patients with sickle cell anemia with recurrent 
	moderate to severe painful crises (generally at least 3 during the preceding 
	Trade Name:	12 months).  
	Droxia	Orphan Designation:
	Treatment of patients with sickle cell anemia as shown by the presence of 
	hemoglobin S.
	Designation 
	10/1/1990	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	2/25/1998	P.O. Box 4000
	Princeton NJ  08543 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Hypericin
	Trade Name:
	Orphan Designation:
	Treatment of glioblastoma multiforme.
	Designation 
	8/3/2000	Sponsor and Address
	Marketing Exclusivity 	Nexell Therapeutics
	2751 Centerville Rd., Suite 210
	Wilmington DE  19808 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hypericin
	Trade Name:
	Orphan Designation:
	Treatment of cutaneous T-cell lymphoma.
	Designation 
	2/7/2000	Sponsor and Address
	Marketing Exclusivity 	Nexell Therapeutics, Inc.
	2751 Centerville Rd., Suite 210
	Wilmington DE  19808 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	I(131)-TM-601 (chlorotoxin)
	Trade Name:
	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	2/14/2002	Sponsor and Address
	Marketing Exclusivity 	TransMolecular, Inc.
	840 Memorial Drive
	Second Floor
	Cambridge MA  02139 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iboctadekin
	Trade Name:
	Orphan Designation:
	Treatment of renal cell carcinoma
	Designation 
	6/3/2005	Sponsor and Address
	Marketing Exclusivity 	SmithKlineBeecham Corporation
	d/b/a GlaxoSmithKline
	P. O. Box 7929
	Philadelphia PA  19101 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ibritumomab tiuxetan	Treatment of patients with relapsed or refractory low-grade, follicular, or 
	transformed B-cell non-Hodgkin?s lymphoma, including patients with 
	Rituximab (Rituxan?) refractory follicular non-Hodgkin?s lymphoma
	Trade Name:
	Zevalin	Orphan Designation:
	Treatment of B-cell non-Hodgkin's lymphoma.
	Designation 
	9/6/1994	Sponsor and Address
	Marketing Exclusivity 	Biogen IDEC Inc.
	2/19/2002	5200 research Place
	San Diego CA  92122 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Ibuprofen i.v. solution
	Trade Name:
	Salprofen	Orphan Designation:
	Prevention of patent ductus arteriosus.
	Designation 
	10/29/1996	Sponsor and Address
	Marketing Exclusivity 	Farmacon-IL, LLC
	1720 Post Road East
	Suite 213
	Westport CT  06880-5643
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ibuprofen lysine	For closure of a clinically significant patent ductus arteriosus in premature 
	infants weighing between 500 and 1500 g, who are no more than 32 weeks 
	gestational age when usual medical management (e.g., fluid restriction, 
	Trade Name:	diuretics, respiratory support, etc.) is  ineffective
	NeoProfen	Orphan Designation:
	Treatment of patent ductus arteriosus.
	Designation 
	10/29/1996	Sponsor and Address
	Marketing Exclusivity 	Farmacon-IL, LLC
	4/13/2006	1720 Post Road East
	Suite 213
	Westport CT  06880-5643
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	icatibant 
	Trade Name:
	Orphan Designation:
	Treatment of burn patients hospitalized with burn-induced edema
	Designation 
	5/5/2004	Sponsor and Address
	Marketing Exclusivity 	Jerini AG
	Invalidenstr, 130
	10115 Berlin
	    
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	icatibant
	Trade Name:
	Orphan Designation:
	Treatment of angioedema
	Designation 
	11/25/2003	Sponsor and Address
	Marketing Exclusivity 	Jerini AG
	Invalidenstr. 130
	10115 Berlin
	    
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Icodextrin 7.5% with Electrolytes Peritoneal Dialysis 	For use as a single daily exchange for the long (8-16 hour) dwell during 
	Solution	continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal 
	dialysis (APD) for the management of chronic renal failure.
	Trade Name:
	Extraneal (with 7.5% Icodextrin) Peritoneal 	Orphan Designation:
	Dialysis Solutio
	Treatment of those patients having end stage renal disease and requiring 
	peritoneal dialysis treatment.
	Designation 
	7/18/1997	Sponsor and Address
	Marketing Exclusivity 	Baxter Healthcare Corporation
	12/20/2002	Renal Division
	1620 Waukegan Road
	McGaw Park IL  60085 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Idarubicin
	Trade Name:
	Idamycin	Orphan Designation:
	Treatment of chronic myelogenous leukemia.
	Designation 
	12/2/1992	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	7000 Portage Road
	Unit 0633-298-113
	Kalamazoo MI  49001-0199
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Idarubicin
	Trade Name:
	Idamycin	Orphan Designation:
	Treatment of myelodysplastic syndromes.
	Designation 
	12/1/1992	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	7000 Portage Road
	Unit 0633-298-113
	Kalamazoo MI  49001-0199
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Idarubicin HCl for injection
	Trade Name:
	Idamycin	Orphan Designation:
	Treatment of acute myelogenous leukemia, also referred to as acute 
	nonlymphocytic leukemia.
	Designation 
	7/25/1988	Sponsor and Address
	Marketing Exclusivity 	Adria Laboratories, Inc.
	9/27/1990	P.O. Box 16529
	Columbus OH  43216 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Idarubicin HCl for injection
	Trade Name:
	Idamycin	Orphan Designation:
	Treatment of acute lymphoblastic leukemia in pediatric patients.
	Designation 
	2/12/1991	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	7000 Portage Road
	Unit 0633-298-113
	Kalamazoo MI  49001-0199
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	idebenone
	Trade Name:
	Orphan Designation:
	Treatment of Leber's hereditary optic neuropathy.
	Designation 
	10/31/2006	Sponsor and Address
	Marketing Exclusivity 	Santhera Pharmaceuticals Limited
	Hammerstrasse 47

	SWITZERLAND
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	idebenone
	Trade Name:
	Orphan Designation:
	Treatment of Duchenne muscular dystrophy
	Designation 
	2/16/2007	Sponsor and Address
	Marketing Exclusivity 	Santhera Pharaceuticals Limited
	Hammerstrasse 47

	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Idebenone
	Trade Name:
	Orphan Designation:
	Treatment of Friedreich's ataxia
	Designation 
	3/25/2004	Sponsor and Address
	Marketing Exclusivity 	Santhera Pharmaceuticals LLC
	Hammerstrasse 25
	CH-4410 Liestal
	    
	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Idoxuridine
	Trade Name:
	Orphan Designation:
	Treatment of nonparenchymatous sarcomas.
	Designation 
	4/8/1996	Sponsor and Address
	Marketing Exclusivity 	NeoPharm, Inc.
	225 East Deerpath, Suite 250
	Lake Forest IL  60045 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	idursulfase	Indicated for patients with Hunter syndrome (mucopolysaccharidosis II, MPS
	 II).  Idursulfase has been shown to improve walking capacity in these 
	patients
	Trade Name:
	Elaprase	Orphan Designation:
	Long term enzyme replacement therapy for patients with 
	mucopolysaccharidosis II (Hunter Syndrome)
	Designation 
	11/28/2001	Sponsor and Address
	Marketing Exclusivity 	Shire Human Genetic Therapies, Inc.
	7/24/2006	700 Main Street
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ifosfamide	In combination with certain other approved antineoplastic agents, for third 
	line chemotherapy in the treatment of germ cell testicular cancer.
	Trade Name:
	Ifex	Orphan Designation:
	Treatment of testicular cancer.
	Designation 
	1/20/1987	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	12/30/1988	5 Research Parkway, P.O. Box 5100
	Wallingford CT  06492 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Ifosfamide
	Trade Name:
	Ifex	Orphan Designation:
	Treatment of bone sarcomas
	Designation 
	8/7/1985	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	P.O. Box 4000
	Princeton NJ  08543-4000
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ifosfamide
	Trade Name:
	Ifex	Orphan Designation:
	Treatment of soft tissue sarcomas.
	Designation 
	8/7/1985	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	P.O. Box 4000
	Princeton NJ  08543 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	IL13-PE38QQR
	Trade Name:
	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	11/2/2001	Sponsor and Address
	Marketing Exclusivity 	NeoPharm, Inc.
	150 Field Drive
	Suite 195
	Lake Forest IL  60045 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	IL-4 Pseudomonas Toxin Fusion Protein (IL-4(38-37)-
	PE38KDEL)
	Trade Name:
	Orphan Designation:
	Treatment of astrocytic glioma.
	Designation 
	4/6/2000	Sponsor and Address
	Marketing Exclusivity 	Protox Therapeutics, Inc.
	1210-885 West Georgia
	Vancouver, British Columbia
	San Diego    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iloprost inhalation solution	Treatment of pulmonary arterial hypertension (WHO Group I) in patients 
	with NYHA Class III or IV symptoms
	Trade Name:
	Ventavis	Orphan Designation:
	Treatment of pulmonary arterial hypertension
	Designation 
	8/17/2004	Sponsor and Address
	Marketing Exclusivity 	CoTherix, Inc.
	12/29/2004	5000 Shoreline Court
	South San Francisco CA  94080 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Iloprost solution for infusion
	Trade Name:
	Orphan Designation:
	Treatment of Raynaud's phenomenon secondary to systemic sclerosis.
	Designation 
	9/21/1989	Sponsor and Address
	Marketing Exclusivity 	Berlex Laboratories, Inc.
	300 Fairfield Road
	Wayne NJ  07470 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iloprost solution for infusion
	Trade Name:
	Orphan Designation:
	Treatment of heparin-associated thrombocytopenia.
	Designation 
	5/14/1990	Sponsor and Address
	Marketing Exclusivity 	Berlex Laboratories, Inc.
	300 Fairfield Road
	Wayne NJ  07470 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imatinib	Treatment of patients with chronic myeloid
	leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after 
	failure of interferon-alpha therapy
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of chronic myelogenous leukemia
	Designation 
	1/31/2001	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	5/10/2001	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imatinib mesylate	Treatment of adult patients with aggressive mastocytosis (ASM) without the 
	D816V c-Kit mutation or with c-Kit mutational status unknown
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of systemic mastocytosis without the D816V c-kit mutation
	Designation 
	9/9/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	10/19/2006	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imatinib mesylate	Treatment of adult patients with myelodysplastic/myeloproliferative 
	diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor 
	receptor) gene re-arrangements
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of myeloproliferative disorders/myelodysplastic syndromes 
	associated with platelet-derived growth factor gene re-arrangements
	Designation 
	10/5/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	10/19/2006	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Imatinib mesylate	Treatment of adult patients with hypereosinophic syndrome (HES) and/or 
	chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRÎ± fusion 
	kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion)
	Trade Name:	 and for patients with HES and/or CEL who are FIP1L1-PDGFRÎ± fusion 
	kinase negative or unknown
	Gleevec	Orphan Designation:
	Treatment of idiopathic hypereosinophilic syndrome including acute and 
	chronic eosinophilic leukemia
	Designation 
	8/25/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	10/19/2006	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	imatinib mesylate	Treatment of adult patients with relapsed or refractory Philadelphia 
	chromosome positive acute lymphoblastic leukemia (Ph+ALL)
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of Philadelphia-positive acute lymphoblastic leukemia
	Designation 
	10/11/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	10/19/2006	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	imatinib mesylate	Treatment of adult patients with unresectable, recurrent and/or metastatic 
	dermatofibrosarcoma protuberans (DFSP)
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of dermatofibrosarcoma protuberans
	Designation 
	12/19/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	10/19/2006	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	imatinib mesylate	Treatment of patients with Kit (CD117) positive unresectable and/or 
	metastatic malignant gastrointestinal stromal tumors (GIST)
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of gastrointestinal  stromal tumors
	Designation 
	11/1/2001	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corp.
	2/1/2002	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imciromab pentetate
	Trade Name:
	Myoscint	Orphan Designation:
	Detecting early necrosis as an indication of rejection of orthotopic cardiac 
	transplants.
	Designation 
	1/25/1989	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	244 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	imexon
	Trade Name:
	Amplimexon	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	8/12/2005	Sponsor and Address
	Marketing Exclusivity 	AmpliMed Corporation
	4380 N. Campbell Ave.
	Tucson AZ  85718 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imexon
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma.
	Designation 
	11/8/1996	Sponsor and Address
	Marketing Exclusivity 	AmpliMed Corporation
	2321 Camino La Zorrela
	Tucson AZ  85718 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imexon
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic adenocarcinoma
	Designation 
	11/1/2003	Sponsor and Address
	Marketing Exclusivity 	AmpliMed Corporation
	2321 Camino La Zorrela
	Tucson AZ  85718 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imexon
	Trade Name:
	Orphan Designation:
	Treatment of metastatic malignant melanoma
	Designation 
	8/3/2001	Sponsor and Address
	Marketing Exclusivity 	AmpliMed Corporation
	2321 Camino La Zorrela
	Tucson AZ  85718 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imiglucerase	Enzyme replacement therapy in patients with type I Gaucher's disease.
	Trade Name:
	Cerezyme	Orphan Designation:
	Replacement therapy in patients with types I, II, and III Gaucher's disease.
	Designation 
	11/5/1991	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	5/23/1994	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Immortalized human liver cells found in the 
	extracorporeal liver assist device
	Trade Name:
	ELAD	Orphan Designation:
	Treatment of fulminant hepatic failure (acute liver failure)
	Designation 
	7/16/2004	Sponsor and Address
	Marketing Exclusivity 	Vital Therapies, Inc.
	15222 Avenue of Science
	Suite C
	San Diego CA  92128 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Immune Globulin (Human)
	Trade Name:
	Gamunex	Orphan Designation:
	Treatment of chronic inflammatory demyelinating polyneuropathy
	Designation 
	7/27/2004	Sponsor and Address
	Marketing Exclusivity 	Talecris
	8368 US 70 West
	Clayton  NC  27520 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Immune Globulin (Human) containing high titers of 
	West Nile virus antibodies
	Trade Name:
	Omr-IgG-am (tm)  5% (WNV)	Orphan Designation:
	Treatment of the West Nile virus infection
	Designation 
	3/17/2004	Sponsor and Address
	Marketing Exclusivity 	OMRIX Biopharmaceuticals, Ltd.
	Plasma Fractionation Institute
	Ramat Gan 52621
	    
	ISRAEL
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Immune Globulin Intravenous (human)
	Trade Name:
	Carimune NF	Orphan Designation:
	Treatment for Guillain Barre Syndrome
	Designation 
	5/4/2004	Sponsor and Address
	Marketing Exclusivity 	ZLB Bioplasma AG
	Wankdorfstrasse 10
	CH-3000 Bern 22
	    
	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Immune globulin intravenous (human)
	Trade Name:
	Gammagard Liquid	Orphan Designation:
	Treatment of multifocal motor neuropathy 
	Designation 
	7/20/2006	Sponsor and Address
	Marketing Exclusivity 	Baxter Healthcare Corporation,
	 Baxter Bioscience
	Westlake Village CA  91362 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Immune globulin intravenous (human)
	Trade Name:
	Immune Globulin Intravenous (human) Immuno, 	Orphan Designation:
	Iveegam
	Treatment of patients with acute myocarditis.
	Designation 
	11/22/1993	Sponsor and Address
	Marketing Exclusivity 	Immuno Clinical Research Corp.
	750 Lexington Avenue
	New York NY  10022 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Immune globulin intravenous (human)
	Trade Name:
	Iveegam, Immuno	Orphan Designation:
	Treatment of polymyositis/dermatomyositis.
	Designation 
	10/13/1992	Sponsor and Address
	Marketing Exclusivity 	Immuno Clinical Research Corp.
	155 East 56th Street
	New York NY  10022 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Immune globulin intravenous (human)
	Trade Name:
	Iveegam, Immuno	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis.
	Designation 
	12/16/1992	Sponsor and Address
	Marketing Exclusivity 	Immuno Clinical Research Corp.
	750 Lexington Avenue, 19th Floor
	New York NY  10022 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Immune globulin intravenous, human	For prophylaxis of children with clinical or immunologic evidence of human
	 immunodeficiency virus to decrease the frequency of serious and minor 
	bacterial infections and the frequency of hospitalization, and to increase 
	Trade Name:	the time free of serious bacterial infections.
	Gamimune N	Orphan Designation:
	Infection prophylaxis in pediatric patients affected with the human 
	immunodeficiency virus.
	Designation 
	2/18/1993	Sponsor and Address
	Marketing Exclusivity 	Bayer Corporation
	12/27/1993	Pharmaceutical Division, Biological Products
	400 Morgan Lane
	New Haven CT  06516 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Immune Globulin Subcutaneous (Human)
	Trade Name:
	Vivaglobin P (proposed)	Orphan Designation:
	Treatment of patients with primary immune deficiency (PID) that are 
	intolerant to immune globulin intravenous (IGIV) due to severe adverse 
	Designation 	events or poor venous access
	9/22/2004	Sponsor and Address
	Marketing Exclusivity 	Aventis Behring, L.L.C.
	1020 First Avenue
	P.O. Box 61501
	King of Prussia PA  19406-0901
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Implitapide
	Trade Name:
	Orphan Designation:
	Treatment of homozygous familial hypercholesterolemia
	Designation 
	8/13/2004	Sponsor and Address
	Marketing Exclusivity 	Medical Research Laboratories International
	2 Tesseneer Drive
	Highland Heights KY  41076 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Implitapide
	Trade Name:
	Orphan Designation:
	Treatment of patients with Fredrickson type I or V hyperlipoproteinemia
	Designation 
	8/19/2004	Sponsor and Address
	Marketing Exclusivity 	Medical Research Laboratories International
	2 Tesseneer Drive
	Highland Heights KY  41076 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imported fire ant venom, allergenic extract
	Trade Name:
	Orphan Designation:
	For skin testing of victims of fire ant stings to confirm fire ant sensitivity and 
	if positive, for use as immunotherapy for the prevention of IgE-mediated 
	Designation 	anaphylactic reactions.
	5/12/1992	Sponsor and Address
	Marketing Exclusivity 	ALK Laboratories, Inc.
	Research Center
	27 Village Lane
	Wallingford CT  06492 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Inalimarev and falimarev
	Trade Name:
	Orphan Designation:
	Treatment of adenocarcinoma of the pancreas
	Designation 
	1/10/2006	Sponsor and Address
	Marketing Exclusivity 	Therion Biologics Corporation
	76 Rogers Street
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Indium In 111 murine monoclonal antibody FAB to 
	myosin
	Trade Name:
	Myoscint	Orphan Designation:
	To aid in the diagnosis of myocarditis.
	Designation 
	8/7/1989	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	244 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Indium In-111 altumomab pentetate
	Trade Name:
	Hybri-ceaker	Orphan Designation:
	Detection of suspected and previously unidentified tumor foci of recurrent 
	colorectal carcinoma.
	Designation 
	2/6/1990	Sponsor and Address
	Marketing Exclusivity 	Hybritech, Inc.
	11095 Torreyanna Road
	San Diego CA  92196 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Indium-111 pentetreotide
	Trade Name:
	NeuroendoMedix	Orphan Designation:
	Treatment of neuroendocrine tumors
	Designation 
	6/16/2006	Sponsor and Address
	Marketing Exclusivity 	RadioIsotope Therapy of America (RITA) Foundation
	9701 Richmond Avenue
	Houston TX  77042 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	infliximab
	Trade Name:
	Remicade	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis
	Designation 
	10/23/2002	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Valley Parkway
	Malvern PA  19355-1307
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	infliximab
	Trade Name:
	Remicade	Orphan Designation:
	Treatment of giant cell arteritis
	Designation 
	5/6/2003	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Infliximab
	Trade Name:
	REMICADE	Orphan Designation:
	Treatment of pediatric (0 to 16 years of age) ulcerative colitis
	Designation 
	11/12/2003	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Infliximab	For reducing signs and symptoms and inducing and maintaining clinical 
	remission in pediatric patients with moderately to severely active Crohn's 
	disease who have had an inadequate response to conventional therapy
	Trade Name:
	REMICADE	Orphan Designation:
	Treatment of pediatric (0 to 16 years of age) Crohn's Disease
	Designation 
	11/12/2003	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	5/19/2006	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Infliximab
	Trade Name:
	Remicade	Orphan Designation:
	Treatment of chronic sarcoidosis
	Designation 
	5/21/2003	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Infliximab	Treatment of moderately to severely active Crohn's disease for the 
	reduction of the signs and symptoms, in patients who have an inadequate 
	response to conventional therapies; and treatment of patients with 
	Trade Name:	fistulizing Crohn's disease for the reduction in the number of draining 
	Remicade	Orphan Designation:
	Treatment of moderately to severely active Crohn's disease for the 
	reduction of the signs and symptoms, in patients who have an inadequate 
	Designation 	response to conventional therapy; and treatment of patients with fistulizing 
	11/14/1995	Crohn's disease for the reduction in the number of draining 
	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	8/24/1998	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	INGN 201
	Trade Name:
	ADVEXIN	Orphan Designation:
	Treatment of  head and neck cancer
	Designation 
	1/27/2003	Sponsor and Address
	Marketing Exclusivity 	Introgen Therapeutics, Inc.
	2250 Holcombe Blvd
	Houston TX  77030 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	INH-A00021
	Trade Name:
	Veronate	Orphan Designation:
	Reduction (prevention) of nosocomial bacteremia caused by staphylococci 
	in very low birth weight infants.
	Designation 
	6/13/2001	Sponsor and Address
	Marketing Exclusivity 	Inhibitex, Inc.
	8995 Westside Parkway
	Suite 150
	Alpharetta GA  30004 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	inolimomab
	Trade Name:
	Leukotac	Orphan Designation:
	Treatment of graft versus host disease
	Designation 
	10/23/2002	Sponsor and Address
	Marketing Exclusivity 	EUSA Pharma
	1980 S. Easton Road
	Suite 250
	Doylestown PA  18901 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Inosine pranobex
	Trade Name:
	Isoprinosine	Orphan Designation:
	Treatment of subacute sclerosing panencephalitis.
	Designation 
	9/20/1988	Sponsor and Address
	Marketing Exclusivity 	Newport Pharmaceuticals
	897 West Sixteenth Street
	Newport Beach CA  92663 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2a	Treatment of chronic myelogenous leukemia.
	Trade Name:
	Roferon A	Orphan Designation:
	Treatment of chronic myelogenous leukemia.
	Designation 
	6/6/1989	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	10/19/1995	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2a (recombinant)
	Trade Name:
	Roferon-A	Orphan Designation:
	Treatment of renal cell carcinoma.
	Designation 
	4/18/1988	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110-1199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2a (recombinant)
	Trade Name:
	Roferon-A	Orphan Designation:
	For the treatment of metastatic malignant melanoma in combination with 
	Teceleukin.
	Designation 
	5/11/1990	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Interferon alfa-2a (recombinant)
	Trade Name:
	Roferon-A	Orphan Designation:
	For the concomitant administration with Teceleukin for the treatment of 
	metastatic renal cell carcinoma.
	Designation 
	5/2/1990	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07119 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2a (recombinant)
	Trade Name:
	Roferon-A	Orphan Designation:
	Treatment of AIDS related Kaposi's sarcoma.
	Designation 
	12/14/1987	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	11/21/1988	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2a (recombinant)
	Trade Name:
	Roferon-A	Orphan Designation:
	For the concomitant administration with fluorouracil for the treatment of 
	advanced colorectal cancer.
	Designation 
	5/14/1990	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110-1199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2a (recombinant)
	Trade Name:
	Roferon-A	Orphan Designation:
	For use in combination with fluorouracil for the treatment of esophageal 
	carcinoma.
	Designation 
	10/27/1989	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110-1199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2b (recombinant)	Treatment of selected patients with AIDS-related Kaposi's sarcoma.
	Trade Name:
	Intron A	Orphan Designation:
	Treatment of AIDS-related Kaposi's sarcoma.
	Designation 
	6/24/1987	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	11/21/1988	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Interferon alfa-2b (recombinant)
	Trade Name:
	Intron A	Orphan Designation:
	Treatment of acute hepatitis B.
	Designation 
	11/17/1988	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2b (recombinant)
	Trade Name:
	Intron A	Orphan Designation:
	Treatment of primary malignant brain tumors.
	Designation 
	5/13/1988	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2b (recombinant)
	Trade Name:
	Intron A	Orphan Designation:
	Treatment of carcinoma in situ of the urinary bladder.
	Designation 
	8/10/1988	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2b (recombinant)
	Trade Name:
	Intron A	Orphan Designation:
	Treatment of invasive carcinoma of the cervix.
	Designation 
	4/18/1988	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2b (recombinant)
	Trade Name:
	Intron A	Orphan Designation:
	Treatment of ovarian carcinoma.
	Designation 
	8/3/1987	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Interferon alfa-2b (recombinant)
	Trade Name:
	Intron A	Orphan Designation:
	Treatment of chronic myelogenous leukemia.
	Designation 
	6/22/1987	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2b (recombinant)
	Trade Name:
	Intron A	Orphan Designation:
	Treatment of metastatic renal cell carcinoma.
	Designation 
	6/22/1987	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2b (recombinant)
	Trade Name:
	Intron A	Orphan Designation:
	Treatment of laryngeal (respiratory) papillomatosis.
	Designation 
	8/17/1988	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2b (recombinant)
	Trade Name:
	Intron A	Orphan Designation:
	Treatment of chronic delta hepatitis.
	Designation 
	5/4/1990	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-nl
	Trade Name:
	Wellferon	Orphan Designation:
	Treatment of human papillomavirus in patients with severe 
	resistant/recurrent respiratory (laryngeal) papillomatosis.
	Designation 
	10/16/1987	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Interferon alfa-nl
	Trade Name:
	Wellferon	Orphan Designation:
	Treatment of AIDS related Kaposi's sarcoma.
	Designation 
	8/25/1986	Sponsor and Address
	Marketing Exclusivity 	Burroughs Wellcome Company
	3030 Cornwallis Road
	Research Triangle Pk NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon beta (recombinant)
	Trade Name:
	R-IFN-beta	Orphan Designation:
	For the systemic treatment of metastatic renal cell carcinoma.
	Designation 
	2/12/1991	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon beta (recombinant)
	Trade Name:
	r-HuIFN-beta	Orphan Designation:
	For the intralesional and/or systemic treatment of AIDS-related Kaposi's 
	sarcoma.
	Designation 
	5/9/1991	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon beta (recombinant)
	Trade Name:
	r-HuIFN-beta	Orphan Designation:
	For the systemic treatment of cutaneous T-cell lymphoma.
	Designation 
	4/18/1991	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon beta, recombinant human
	Trade Name:
	Betaseron	Orphan Designation:
	Treatment of acquired immunodeficiency syndrome.
	Designation 
	11/15/1988	Sponsor and Address
	Marketing Exclusivity 	Berlex Laboratories, Inc.
	15049 San Pablo Avenue, P.O. Box 4099
	Richmond CA  94804 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Interferon beta-1a
	Trade Name:
	Rebif	Orphan Designation:
	Treatment of patients with secondary progressive multiple sclerosis.
	Designation 
	3/11/1996	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon beta-1a	Treatment of relapsing forms of multiple sclerosis to slow the accumulation 
	of physical disability and decrease the frequency of clinical exacerbations.
	Trade Name:
	Avonex	Orphan Designation:
	Treatment of multiple sclerosis.
	Designation 
	12/16/1991	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	5/17/1996	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	interferon Beta-1a
	Trade Name:
	Avonex	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis.
	Designation 
	10/14/1998	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon beta-1a (recombinant human)
	Trade Name:
	Orphan Designation:
	Treatment of acute non-A, non-B hepatitis.
	Designation 
	7/24/1992	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon beta-1a (recombinant)
	Trade Name:
	r-HuIFN-beta	Orphan Designation:
	For the systemic treatment of cutaneous malignant melanoma.
	Designation 
	4/3/1991	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Interferon beta-1a (recombinant)
	Trade Name:
	Rebif	Orphan Designation:
	Treatment of symptomatic patients with AIDS including all patients with 
	CD4 T-cell counts less than 200 cells per mm3.
	Designation 
	12/2/1992	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon beta-1b	In ambulatory patients with relapsing-remitting multiple sclerosis to reduce 
	the frequency of clinical exacerbations.
	Trade Name:
	Betaseron	Orphan Designation:
	Treatment of multiple sclerosis.
	Designation 
	11/17/1988	Sponsor and Address
	Marketing Exclusivity 	Chiron Corp. & Berlex Laboratories
	7/23/1993	4560 Horton Street
	Emeryville CA  94608 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon gamma
	Trade Name:
	Orphan Designation:
	Treatment of idiopathic pulmonary fibrosis
	Designation 
	10/11/2007	Sponsor and Address
	Marketing Exclusivity 	Foundation for Fatal Rare Diseases
	Herrengasse 21
	Furstentum Liechtenstein
	    
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon gamma 1-b
	Trade Name:
	Actimmune	Orphan Designation:
	Treatment of chronic granulomatous disease.
	Designation 
	9/30/1988	Sponsor and Address
	Marketing Exclusivity 	InterMune, Inc.
	12/20/1990	3280 Bayshore Blvd
	Brisbane CA  94005 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon gamma-1b	Delaying time to disease progression in patients with severe, malignant 
	osteopetrosis.
	Trade Name:
	Actimmune	Orphan Designation:
	Delaying time to disease progression in patients with severe, malignant 
	osteopetrosis.
	Designation 
	9/30/1996	Sponsor and Address
	Marketing Exclusivity 	InterMune , Inc.
	2/10/2000	1710 Gilbreth Road, 
	Suite 301
	Burlingame CA  94010-1317
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	interferon gamma-1b
	Trade Name:
	Actimmune	Orphan Designation:
	Treatment of idiopathic pulmonary fibrosis
	Designation 
	9/12/2002	Sponsor and Address
	Marketing Exclusivity 	InterMune, Inc.
	3280 Bayshore Boulevard
	Brisbane CA  94005 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon gamma-1b
	Trade Name:
	Actimmune	Orphan Designation:
	Treatment of renal cell carcinoma.
	Designation 
	12/4/1995	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1 DNA Way
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon-alfa-1b
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	4/17/2001	Sponsor and Address
	Marketing Exclusivity 	Ernest C.Borden
	Center for Cancer Drud Discovery and Development
	9500  Euclid Avenue
	Clevland OH  44195 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interleukin-1 alpha, human recombinant
	Trade Name:
	Orphan Designation:
	For hematopoietic potentiation in aplastic anemia.
	Designation 
	6/17/1991	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	51 University Street
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interleukin-1 alpha, human recombinant
	Trade Name:
	Orphan Designation:
	For the promotion of early engraftment in bone marrow transplantation.
	Designation 
	6/17/1991	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	51 University Street
	Seattle WA  98101 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Interleukin-1 receptor antagonist, human 
	recombinant
	Trade Name:
	Antril	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis.
	Designation 
	9/23/1991	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	One Amgen Center Drive
	Thousand Oaks CA  91320-1799
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interleukin-1 receptor antagonist, human 
	recombinant
	Trade Name:
	Antril	Orphan Designation:
	Prevention and treatment of graft versus host disease in transplant 
	recipients.
	Designation 
	10/16/1992	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	One Amgen Center Drive
	Thousand Oaks CA  91320-1799
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interleukin-1 Trap
	Trade Name:
	Orphan Designation:
	Treatment of Still's disease including juvenile rheumatoid arthritis and 
	adult-onset Still's disease
	Designation 
	4/4/2005	Sponsor and Address
	Marketing Exclusivity 	Regeneron Pharmaceuticals, Inc.
	777 Old Saw Mill River Road
	Tarrytown NY  10591 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interleukin-2
	Trade Name:
	Teceleukin	Orphan Designation:
	In combination with interferon alfa-2a for the treatment of metastatic 
	malignant melanoma.
	Designation 
	5/11/1990	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interleukin-2
	Trade Name:
	Teleleukin	Orphan Designation:
	Treatment of metastatic malignant melanoma.
	Designation 
	2/6/1990	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Interleukin-2
	Trade Name:
	Teceleukin	Orphan Designation:
	Treatment of metastatic renal cell carcinoma.
	Designation 
	2/5/1990	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interleukin-2
	Trade Name:
	Teceleukin	Orphan Designation:
	In combination with interferon alfa-2a for the treatment of metastatic renal 
	cell carcinoma.
	Designation 
	5/3/1990	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interleukin-3 human (recombinant)
	Trade Name:
	Orphan Designation:
	Promotion of erythropoiesis in Diamond-Blackfan anemia (congenital pure 
	red cell aplasia).
	Designation 
	5/20/1991	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	51 University Street
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interleukin-3, human, recombinant
	Trade Name:
	Orphan Designation:
	For sequential administration with sargramostim to accelerate neutrophil 
	and platelet recovery in patients undergoing autologous bone marrow 
	Designation 	transplantation for the treatment of Hodgkin's disease or non-Hodgkin's 
	9/30/1993	Sponsor and Address	lymphoma.
	Marketing Exclusivity 	Sandoz Pharmaceuticals Corp.
	59 Route 10
	East Hanover NJ  07936 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Intraoral fluoride releasing system
	Trade Name:
	IFRS	Orphan Designation:
	Prevention of dental caries due to radiation-induced xerostomia in patients 
	with head and neck cancer
	Designation 
	7/31/2001	Sponsor and Address
	Marketing Exclusivity 	Digestive Care, Inc.
	1120 Win Drive
	Bethlehem PA  18017 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Intravenous immune globulin
	Trade Name:
	VitiGam	Orphan Designation:
	Treatment of Stage IIB to IV malignant melanoma
	Designation 
	7/26/2007	Sponsor and Address
	Marketing Exclusivity 	GammaCan Ltd.
	39 Jerusalem Street

	ISRAEL
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iobenguane I 123
	Trade Name:
	Orphan Designation:
	For the diagnosis of pheochromocytoma.
	Designation 
	12/1/2006	Sponsor and Address
	Marketing Exclusivity 	GE Healthcare, Inc.
	101 Carnegie Center
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iobenguane I 123
	Trade Name:
	Orphan Designation:
	For the diagnosis of neuroblastomas
	Designation 
	12/1/2006	Sponsor and Address
	Marketing Exclusivity 	GE Healthcare, Inc.
	101 Carnegie Center
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	iobenguane I 131
	Trade Name:
	Orphan Designation:
	Treatment of neuroendocrine tumors
	Designation 
	7/5/2007	Sponsor and Address
	Marketing Exclusivity 	DraxImage
	Div. of Draxis Specialty Pharmaceuticals, Inc.
	Kirkland, Quebec  H9H 4J4
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iobenguane I 131
	Trade Name:
	Azedra Ultratrace	Orphan Designation:
	Treatment of neuroendocrine tumors
	Designation 
	1/18/2006	Sponsor and Address
	Marketing Exclusivity 	Molecular Insight Pharmaceuticals
	160 Second street
	Cambridge MA  02142 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Iobenguane Sulfate I 131	Adjunctive diagnostic agent in the localization of primary or metastatic 
	pheochromocytomas.
	Trade Name:
	Orphan Designation:
	For use as a diagnostic adjunct in patients with pheochromocytoma.
	Designation 
	11/14/1984	Sponsor and Address
	Marketing Exclusivity 	University of Michigan
	3/21/1990	UH B1 H410/0028
	1500 E. Medical Center Drive
	Ann Arbor MI  48109-0028
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iobenguane Sulfate I-123
	Trade Name:
	OmaClear	Orphan Designation:
	For scintigraphic detection, localization and staging of neuroblastoma.
	Designation 
	10/17/2005	Sponsor and Address
	Marketing Exclusivity 	Brogan Pharmaceuticals, LLC
	312 Lacebark Street
	Schererville IN  46375 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	iobenguane sulfate I-123
	Trade Name:
	OmaClear	Orphan Designation:
	For the detection, localization, and staging of pheochromocytomas.
	Designation 
	10/21/2005	Sponsor and Address
	Marketing Exclusivity 	Brogan Pharmaceuticals, Inc.
	9800 Connecticut Drive
	c/o Purdue Technology Center
	Crown Point IN  46307 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iodine 131 6B-iodomethyl-19-norcholesterol
	Trade Name:
	Orphan Designation:
	For use in adrenal cortical imaging.
	Designation 
	8/1/1984	Sponsor and Address
	Marketing Exclusivity 	David E. Kuhl, M.D.
	University of Michigan Medical Center/1500 E. Med.
	B1G412 /0028 University Hospital
	Ann Arbor MI  48109-0028
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iodine I 123 murine monoclonal antibody to alpha-
	fetoprotein
	Trade Name:
	Orphan Designation:
	Detection of alpha-fetoprotein producing germ cell tumors.
	Designation 
	9/30/1988	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Iodine I 123 murine monoclonal antibody to alpha-
	fetoprotein
	Trade Name:
	Orphan Designation:
	Detection of hepatocellular carcinoma and hepatoblastoma.
	Designation 
	9/30/1988	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iodine I 123 murine monoclonal antibody to hCG
	Trade Name:
	Orphan Designation:
	Detection of hCG producing tumors such as germ cell and trophoblastic cell
	 tumors.
	Designation 
	11/7/1988	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iodine I 131 bis(indium-
	diethylenetriaminepentaacetic 
	acid)tyrosyllysine/hMN-14 x m734 F(ab')2 bispecific 
	Trade Name:
	Pentacea	Orphan Designation:
	Treatment of small-cell lung cancer.
	Designation 
	2/22/2000	Sponsor and Address
	Marketing Exclusivity 	IBC Pharmaceuticals, L.L.C.
	300 American Rd.
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iodine I 131 Lym-1 Monoclonal Antibody
	Trade Name:
	Orphan Designation:
	Treatment of B-cell lymphoma.
	Designation 
	11/2/1987	Sponsor and Address
	Marketing Exclusivity 	Lederle Laboratories Division
	American Cyanamide Company
	401 N. Middletown Road
	Pearl River NY  10965 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iodine I 131 murine monoclonal antibody IgG2a to B
	 cell
	Trade Name:
	Immurait, Ll-2-I-131	Orphan Designation:
	Treatment of B-cell leukemia and B-cell lymphoma.
	Designation 
	9/18/1989	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Iodine I 131 murine monoclonal antibody to alpha-
	fetoprotein
	Trade Name:
	Orphan Designation:
	Treatment of alpha-fetoprotein producing germ cell tumors.
	Designation 
	9/30/1988	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iodine I 131 murine monoclonal antibody to alpha-
	fetoprotein
	Trade Name:
	Orphan Designation:
	Treatment of hepatocellular carcinoma and hepatoblastoma.
	Designation 
	9/30/1988	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iodine I 131 murine monoclonal antibody to hCG
	Trade Name:
	Orphan Designation:
	Treatment of hCG producing tumors such as germ cell and trophoblastic 
	cell tumors.
	Designation 
	11/7/1988	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iodine I-131 radiolabeled chimeric MAb tumor 
	necrosis treatment (TNT-1B)
	Trade Name:
	131IchTNT-1	Orphan Designation:
	Treatment of glioblastoma multiforme and anaplastic astrocytoma.
	Designation 
	2/12/1999	Sponsor and Address
	Marketing Exclusivity 	Peregrine Pharmaceuticals, Inc.
	14282 Franklin Ave.
	Tustin CA  92780-7017
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	irofulven
	Trade Name:
	Orphan Designation:
	Treatment of renal cell carcinoma.
	Designation 
	7/27/1999	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma, Inc.
	5775 West Old Shakoppe Rd.
	Suite 100
	Bloomington MN  55437-3107
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	irofulven
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	7/6/1999	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma, Inc.
	5775  West Old Shakoppe Rd.
	Suite 100
	Bloomington MN  55437-3107
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	iron(III)-hexacyanoferrate(II)	Treatment of patients with known or suspected internal contamination with 
	radioactive cesium and/or radioactive or non-radioactive thallium to 
	increase their rates of elimination
	Trade Name:
	Radiogardase	Orphan Designation:
	Treatment of patients with known or suspected internal contamination with 
	radioactive or non-radioactive cesium or thallium
	Designation 
	5/1/2003	Sponsor and Address
	Marketing Exclusivity 	Heyl Chemisch-Pharmzeutische Fabrik GMBH & Co, KG
	10/2/2003	Goerzallee 253
	D-14167 Berlin, Federal Republic of Germany
	    
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Isobutyramide
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell disease and beta thalassemia.
	Designation 
	5/25/1994	Sponsor and Address
	Marketing Exclusivity 	Alpha Therapeutic Corporation
	5555 Valley Boulevard
	Los Angeles CA  90032 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Isobutyramide
	Trade Name:
	Isobutyramide oral solution	Orphan Designation:
	Treatment of beta-hemoglobinopathies and beta-thalassemia syndromes.
	Designation 
	12/18/1992	Sponsor and Address
	Marketing Exclusivity 	Perrine, Susan P., M.D.
	Boston University
	Cancer Research Center
	Boston MA  02118 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	isofagomine tartrate
	Trade Name:
	Orphan Designation:
	Treatment of Gaucher disease
	Designation 
	1/10/2006	Sponsor and Address
	Marketing Exclusivity 	Amicus Therapeutics, Inc.
	6 Cedar Brook Drive
	Cranbury NJ  08512 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Japanese encephalitis vaccine (live, attenuated)
	Trade Name:
	Orphan Designation:
	Prevention of Japanese encephalitis.
	Designation 
	5/19/1999	Sponsor and Address
	Marketing Exclusivity 	Glovax Co., Ltd.
	Room 307, Koryo Academytel, 437-3
	Ahyun-Dong, Mapo-Gu, Seoul 121-010
	    
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ketoconazole
	Trade Name:
	Nizoral	Orphan Designation:
	For use with cyclosporine A to diminish the nephrotoxicity induced by 
	cyclosporine in organ transplantation.
	Designation 
	3/27/1991	Sponsor and Address
	Marketing Exclusivity 	Pharmedic Company
	28101 Ballard Road
	Lake Forest IL  60045 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-2-oxothiazolidine-4-carboxylic acid
	Trade Name:
	Procysteine	Orphan Designation:
	Treatment of adult respiratory distress syndrome.
	Designation 
	6/14/1994	Sponsor and Address
	Marketing Exclusivity 	Transcend Therapeutics, Inc.
	640 Memorial Drive, 3rd Floor West
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-2-oxothiazolidine-4-carboxylic acid
	Trade Name:
	Procysteine	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis.
	Designation 
	7/30/1996	Sponsor and Address
	Marketing Exclusivity 	Transcend Therapeutics, Inc.
	640 Memorial Drive, 3rd Floor West
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-5-hydroxytryptophan
	Trade Name:
	Orphan Designation:
	Treatment of tetrahydrobiopterin deficiency.
	Designation 
	1/20/1999	Sponsor and Address
	Marketing Exclusivity 	Watson Laboratories, Inc.
	311 Bonnie Circle
	P.O. Box 1900
	Corona CA  91718-1900
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Lactic acid
	Trade Name:
	Aphthaid	Orphan Designation:
	Treatment of severe aphthous stomatitis in severely, terminally 
	immunocompromised patients.  
	Designation 
	6/29/1999	Sponsor and Address
	Marketing Exclusivity 	Frontier Pharmaceutical, Inc.
	SUNY Farmingdale
	Conklin Hall
	Farmingdale NY  11735 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	lactic acid bacteria (Lactobacilli, Bifidobacteria, and 
	Steptococci)
	Trade Name:
	Orphan Designation:
	Treatment of active chronic pouchitis
	Designation 
	1/15/2002	Sponsor and Address
	Marketing Exclusivity 	VSL Pharmaceuticals, Inc.
	800 S. Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	lactic acid bacteria (Lactobacilli, Bifidobacteria, and 
	Streptococcus species)
	Trade Name:
	Orphan Designation:
	Prevention of disease relapse in patients with chronic pouchitis
	Designation 
	1/15/2002	Sponsor and Address
	Marketing Exclusivity 	VSL Pharmaceuticals, Inc.
	800 S. Frederick Ave.
	Gaithersburg MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lactobin
	Trade Name:
	Lactobin	Orphan Designation:
	Treatment of AIDS-associated diarrhea unresponsive to initial antidiarrheal 
	therapy.
	Designation 
	9/12/1990	Sponsor and Address
	Marketing Exclusivity 	Roxane Laboratories, Inc.
	P.O. Box 16532
	Columbus OH  43216-6532
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-aminocarnityl-succinyl-leucyl-argininal-diethylacetal
	Trade Name:
	Orphan Designation:
	Treatment of Duchenne and Becker muscular dystrophy
	Designation 
	1/18/2006	Sponsor and Address
	Marketing Exclusivity 	CepTor Corporation
	200 International Circle
	Hunt Valley MD  21030 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Lamotrigine	Adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult 
	patients.
	Trade Name:
	Lamictal	Orphan Designation:
	Treatment of Lennox-Gastaut syndrome.
	Designation 
	8/23/1995	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Research and Development
	8/24/1998	5 Moore Drive
	P.O. Box 13398
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lanreotide	Long-term treatment of acromegalic patients who have had an inadequate 
	response to or cannot be treated with surgery and/or radiotherapy
	Trade Name:
	Somatuline Depot	Orphan Designation:
	Treatment for acromegly
	Designation 
	9/11/2000	Sponsor and Address
	Marketing Exclusivity 	IPSEN, Inc.
	8/30/2007	27 Maple Street
	Milford MA  01757 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	laronidase	Treatment for patients with Hurler and Hurler-Scheie forms of 
	Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who 
	have moderate to severe symptoms
	Trade Name:
	Aldurazyme	Orphan Designation:
	Treatment of patients with mucopolysaccharidosis-I.  
	Designation 
	9/24/1997	Sponsor and Address
	Marketing Exclusivity 	BioMarin Pharmaceutical, Inc.
	4/30/2003	371 Bel Marin Keys Boulevard, Suite 210
	Novato CA  94949-5608
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Latrodectus immune F(ab)2
	Trade Name:
	Aracmyn	Orphan Designation:
	Treatment of black widow spider envenomations
	Designation 
	6/18/2001	Sponsor and Address
	Marketing Exclusivity 	Rare Disease Therapeutics, Inc.
	1101 Kermit Drive, Suite 608
	Nashville TN  37217 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-Baclofen
	Trade Name:
	Neuralgon	Orphan Designation:
	Treatment of intractable spasticity in children with cerebral palsy.
	Designation 
	1/30/1992	Sponsor and Address
	Marketing Exclusivity 	Pharmascience Inc.
	6111 Royalmount, Suite 100
	Montreal, Quebec  H4P 2T4
	    
	CANADA
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	L-baclofen
	Trade Name:
	Neuralgon	Orphan Designation:
	Treatment of intractable spasticity associated with spinal cord injury or 
	multiple sclerosis.
	Designation 
	12/17/1991	Sponsor and Address
	Marketing Exclusivity 	Pharmascience Inc.
	6111 Royalmount, Suite 100
	Montreal, Quebec  H4P 2T4
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-Baclofen
	Trade Name:
	Orphan Designation:
	Treatment of trigeminal neuralgia.
	Designation 
	1/6/1998	Sponsor and Address
	Marketing Exclusivity 	Pharmascience Inc.
	6111 Royalmount, #100
	Montreal, Quebec  H4P 2T4
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-baclofen
	Trade Name:
	Orphan Designation:
	Treatment of trigeminal neuralgia.
	Designation 
	7/13/1990	Sponsor and Address
	Marketing Exclusivity 	Fromm, Gerhard M.D.
	University Of Pittsburgh School of Medicine
	Pittsburgh PA  15261 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-cycloserine
	Trade Name:
	Orphan Designation:
	Treatment of Gaucher's disease.
	Designation 
	8/1/1989	Sponsor and Address
	Marketing Exclusivity 	Lev, Meir M.D.
	The City College, City University Of NY Medical Sc
	Convent Avenue at 138 Street
	New York NY  10031 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-cysteine
	Trade Name:
	Orphan Designation:
	For the prevention and lessening of photosensitivity in erythropoietic 
	protoporphyria.
	Designation 
	5/16/1994	Sponsor and Address
	Marketing Exclusivity 	Brigham and Women's Hospital
	Channing Laboratory
	Dept. of Medicine
	Boston MA  02115 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Leflunomide
	Trade Name:
	Orphan Designation:
	Prevention of acute and chronic rejection in patients who have received 
	solid organ transplants.
	Designation 
	10/18/1996	Sponsor and Address
	Marketing Exclusivity 	Williams, MD, James W.
	Rush-Presbyterian-St. Luke's Medical Ctr., Dept. o
	1653 West Congress Parkway
	Chicago IL  60612-3833
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	lenalidomide	Treatment of patients with transfusion dependant anemia due to low or 
	intermediate-1 risk myelodysplastic syndromes associated with a deletion 5 
	q cytogenetic abnormality with or without additional cytogenetic 
	Trade Name:	abnormalities
	Revlimid	Orphan Designation:
	Treatment of myelodysplastic syndromes
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	12/27/2005	86 Morris Avenue
	Summit NJ  07901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	lenalidomide
	Trade Name:
	Revlimid	Orphan Designation:
	Treatment of chronic lymphocytic leukemia.
	Designation 
	1/17/2007	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	86 Morris Avenue
	Summit NJ  07901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	lenalidomide	For use in combination with dexamethasone for the treatment of multiple 
	myeloma patients who have received at least one prior therapy.
	Trade Name:
	Revlimid 	Orphan Designation:
	Treatment for multiple myeloma
	Designation 
	9/20/2001	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	6/29/2006	86 Morris Avenue
	Summit NJ  07901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lentiviral vector encoded with a human beta-globin 
	gene plasmid
	Trade Name:
	Thalagen	Orphan Designation:
	Treatment of beta-thalassemia major and beta-thalassemia intermedia
	Designation 
	1/11/2006	Sponsor and Address
	Marketing Exclusivity 	Errant Gene Therapeutics, LLC
	200 West Jackson Blvd.
	Chicago IL  60606 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Lepirudin	For anticoagulation in patients with heparin-induced thrombocytopenia and
	 associated thromboembolic disease in order to prevent further 
	thromboembolic complications.
	Trade Name:
	Refluden	Orphan Designation:
	Treatment of heparin-associated thrombocytopenia type II.
	Designation 
	2/13/1997	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel
	3/6/1998	Frankfurt am Main
	P.O. Box 1140
	Marburg     
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lestaurtinib
	Trade Name:
	Orphan Designation:
	Treatment of acute myeloid leukemia
	Designation 
	3/24/2006	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	41 Moores Road
	Frazer PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Leucovorin	For use in combination with 5-fluorouracil to prolong survival in the 
	palliative treatment of patients with advanced colorectal cancer.
	Trade Name:
	Leucovorin calcium	Orphan Designation:
	For use in combination with 5-fluorouracil for the treatment of metastatic 
	colorectal cancer.
	Designation 
	12/8/1986	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	12/12/1991	51 University Street
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Leucovorin
	Trade Name:
	Leucovorin calcium	Orphan Designation:
	For rescue use after high dose methotrexate therapy in the treatment of 
	osteosarcoma.
	Designation 
	8/17/1988	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	8/31/1988	51 University Street
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Leucovorin calcium
	Trade Name:
	Wellcovorin	Orphan Designation:
	For use in combination with 5-fluorouracil for the treatment of metastatic 
	colorectal cancer.
	Designation 
	6/23/1988	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Research and Development
	5 Moore Drive
	PO Box 13398
	Research Triangle Park NC  27709 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	leukocyte interlukin
	Trade Name:
	Multikine	Orphan Designation:
	Neoadjuvant therapy in patients with Squamous Cell Carcinoma of the 
	Head and Neck 
	Designation 
	5/4/2007	Sponsor and Address
	Marketing Exclusivity 	CEL-SCI Corporation
	8229 Boone Blvd.
	Suite 802
	Vienna VA  22182 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Leupeptin
	Trade Name:
	Orphan Designation:
	For use as an adjunct to microsurgical peripheral nerve repair.
	Designation 
	9/18/1990	Sponsor and Address
	Marketing Exclusivity 	Neuromuscular Adjuncts, Inc.
	S.U.N.Y. at Stony Brook
	H.S.C. T18-020
	Stony Brook NY  11794-8181
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Leuprolide acetate	Treatment of children with central precocious puberty.
	Trade Name:
	Lupron Injection	Orphan Designation:
	Treatment of central precocious puberty.
	Designation 
	7/25/1988	Sponsor and Address
	Marketing Exclusivity 	Tap Pharmaceuticals, Inc.
	4/16/1993	2355 Waukegan Road
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levocabastine HCl ophthalmic suspension 0.05%
	Trade Name:
	Orphan Designation:
	Treatment of vernal keratoconjunctivitis.
	Designation 
	2/29/1988	Sponsor and Address
	Marketing Exclusivity 	Iolab Pharmaceuticals
	500 Iolab Drive
	Claremont CA  94608 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levocarnitine	Prevention and treatment of carnitine deficiency in patients with end stage 
	renal disease who are undergoing dialysis.  
	Trade Name:
	Carnitor	Orphan Designation:
	Treatment of manifestations of carnitine deficiency in patients with end 
	stage renal disease who require dialysis.
	Designation 
	9/6/1988	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	12/15/1999	800 South Frederick Avenue, Suite 300
	Gaithersburg MD  20877 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Levocarnitine
	Trade Name:
	Carnitor	Orphan Designation:
	Treatment of manifestations of carnitine deficiency in patients with end 
	stage renal disease who require dialysis.
	Designation 
	11/24/1986	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	800 South Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levocarnitine
	Trade Name:
	Carnitor	Orphan Designation:
	For the treatment of secondary carnitine deficiency in valproic acid toxicity.
	Designation 
	11/15/1989	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	800 South Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levocarnitine
	Trade Name:
	Carnitor	Orphan Designation:
	For the prevention of secondary carnitine deficiency in valproic acid toxicity.
	Designation 
	11/15/1989	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	800 South Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levocarnitine
	Trade Name:
	Carnitor	Orphan Designation:
	Treatment of zidovudine-induced mitochondrial myopathy.
	Designation 
	4/7/1997	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	800 S. Frederick Avenue, Suite 300
	Gaithersburg MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levocarnitine
	Trade Name:
	Carnitor	Orphan Designation:
	Treatment of pediatric cardiomyopathy.
	Designation 
	11/22/1993	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	800 South Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Levocarnitine	Treatment of primary systemic carnitine deficiency. (approved 12/27/85)  
	Treatment of secondary carnitine deficiency. (approved 12/16/92)
	Trade Name:
	Carnitor	Orphan Designation:
	Treatment of primary and secondary carnitine deficiency of genetic origin.
	Designation 
	7/26/1984	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	12/16/1992	800 South Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levocarnitine
	Trade Name:
	Carnitor	Orphan Designation:
	Treatment of genetic carnitine deficiency.
	Designation 
	2/28/1984	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	4/10/1986	800 South Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levodopa and carbidopa
	Trade Name:
	Duodopa	Orphan Designation:
	Treatment of late stage Parkinson's disease.  
	Designation 
	1/18/2000	Sponsor and Address
	Marketing Exclusivity 	Solvay Pharmaceuticals, Inc.
	901 Sawyer Road
	Marietta GA  30062 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levofloxacin
	Trade Name:
	Orphan Designation:
	Treatment of pulmonary infections due to Pseudomonas aeruginosa and 
	other bacteria in patients with cystic fibrosis patients
	Designation 
	2/27/2008	Sponsor and Address
	Marketing Exclusivity 	Mpex Pharmaceuticals, Inc.
	11535 Sorrento Valley Road
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levoleucovorin	Levoleucovorin rescue is indicated after high-dose methotrexate therapy in 
	osteosarcoma. Levoleucovorin is also indicated to diminish the toxicity and 
	counteract the effects of impaired methotrexate elimination and of 
	Trade Name:	inadvertent overdosage of folic acid antagonists
	Orphan Designation:
	For use in conjunction with high-dose methotrexate in the treatment of 
	osteosarcoma.
	Designation 
	8/1/1991	Sponsor and Address
	Marketing Exclusivity 	Spectrum Pharmaceuticals, Inc.
	3/7/2008	157 Technology Drive
	Irgine CA  92618 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Levomethadyl acetate hydrochloride	For the management of opiate dependence.
	Trade Name:
	Orlaam	Orphan Designation:
	Treatment of heroin addicts suitable for maintenance on opiate agonists.
	Designation 
	1/24/1985	Sponsor and Address
	Marketing Exclusivity 	Biodevelopment Corporation
	7/9/1993	8180 Greensboro Drive, Suite 1000
	McLean VA  22102 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-glutamine
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell disease
	Designation 
	8/1/2001	Sponsor and Address
	Marketing Exclusivity 	Emmaus Medical, Inc.
	3870 Del Amo Blvd
	Unit 507
	Torrance CA  90503-7701
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-glutamyl-L-tryptophan
	Trade Name:
	Orphan Designation:
	Treatment of AIDS-related Kaposi's sarcoma.  
	Designation 
	10/20/1999	Sponsor and Address
	Marketing Exclusivity 	Implicit Bioscience Pty Ltd
	P. O. Box 2072.
	Toowong Business Center
	    
	AUSTRALIA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	liarozole
	Trade Name:
	Orphan Designation:
	The treatment of congenital ichthyosis
	Designation 
	6/18/2004	Sponsor and Address
	Marketing Exclusivity 	Barrier Therapeutics, Inc
	600 College Road East
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lidocaine patch 5%
	Trade Name:
	Lidoderm Patch	Orphan Designation:
	For relief of allodynia (painful hypersensitivity), and chronic pain in 
	postherpetic neuralgia. 
	Designation 
	10/24/1995	Sponsor and Address
	Marketing Exclusivity 	Teikoku Pharma USA, Inc.
	3/19/1999	745-D Camden Ave.
	Campbell CA  95008-4146
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Lintuzumab
	Trade Name:
	Orphan Designation:
	Treatment of myelodysplastic syndrome.
	Designation 
	3/20/2007	Sponsor and Address
	Marketing Exclusivity 	Seattle Genetics, Inc.
	21823 30th Drive Southeast
	Bothell WA  98021 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	lintuzumab
	Trade Name:
	Orphan Designation:
	Treatment of acute myeloid leukemia.
	Designation 
	1/30/2007	Sponsor and Address
	Marketing Exclusivity 	Seattle Genetics, Inc.
	21823 30th Drive Southeast
	Bothell WA  98021 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	lintuzumab
	Trade Name:
	Zamyl	Orphan Designation:
	Treatment of acute myelogenous leukemia
	Designation 
	9/9/2002	Sponsor and Address
	Marketing Exclusivity 	Protein Design Labs, Inc.
	34801 Campus Drive
	Fremont CA  94555 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liothyronine sodium injection	Treatment of myxedema coma/precoma.
	Trade Name:
	Triostat	Orphan Designation:
	Treatment of myxedema coma/precoma.
	Designation 
	7/30/1990	Sponsor and Address
	Marketing Exclusivity 	SmithKline Beecham Pharmaceuticals
	12/31/1991	One Franklin Plaza
	P.O. Box 7929
	Philadelphia PA  19101 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lipid/DNA human cystic fibrosis gene
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	4/8/1996	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	Metrowest Place
	P.O. Box  9322
	Framingham MA  01701-9322
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Liposomal amphotericin B
	Trade Name:
	AmBisome	Orphan Designation:
	Treatment of histoplasmosis.
	Designation 
	12/10/1996	Sponsor and Address
	Marketing Exclusivity 	Fujisawa USA, Inc.
	3 Parkway North Center
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal amphotericin B	Treatment of visceral leishmaniasis.
	Trade Name:
	AmBisome	Orphan Designation:
	Treatment of visceral leishmaniasis.
	Designation 
	12/6/1996	Sponsor and Address
	Marketing Exclusivity 	Fujisawa USA, Inc.
	8/11/1997	3 Parkway North Center
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal amphotericin B	Treatment of disseminated cryptococcosis including meningitis.
	Trade Name:
	AmBisome	Orphan Designation:
	Treatment of cryptococcal meningitis.
	Designation 
	12/10/1996	Sponsor and Address
	Marketing Exclusivity 	Fujisawa USA, Inc.
	8/11/1997	3 Parkway North Center
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal annamycin
	Trade Name:
	Orphan Designation:
	Treatment of acute myeloid leukemia
	Designation 
	6/17/2005	Sponsor and Address
	Marketing Exclusivity 	Callisto Pharmaceuticals, Inc.
	420 Lexington Avenue
	New York NY  10170 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal annamycin
	Trade Name:
	Orphan Designation:
	Treatment of acute lymphoblastic leukemia
	Designation 
	6/17/2005	Sponsor and Address
	Marketing Exclusivity 	Callisto Pharmaceuticals, Inc.
	420 Lexington Avenue
	New York  NY  10170 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Liposomal ciprofloxacin
	Trade Name:
	Orphan Designation:
	Management of bronchiectasis
	Designation 
	12/27/2006	Sponsor and Address
	Marketing Exclusivity 	Aradigm Corporation
	3929 Point Eden Way
	Hayward CA  94545 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal ciprofloxacin for inhalation
	Trade Name:
	Orphan Designation:
	Management of cystic fibrosis
	Designation 
	4/19/2006	Sponsor and Address
	Marketing Exclusivity 	Aradigm Corporation
	3929 Point Eden Way
	Hayward CA  94545 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal cisplatin 
	Trade Name:
	LipOva-Pt	Orphan Designation:
	Treatment of ovarian cancer
	Designation 
	5/23/2006	Sponsor and Address
	Marketing Exclusivity 	Transave, Inc.
	11 Deer Park Drive
	Monmouth Junction NJ  08852-1923
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal cyclosporin A
	Trade Name:
	Cyclospire	Orphan Designation:
	For aerosolized administration in the prevention and treatment of lung 
	allograft rejection 
	Designation 	and pulmonary rejection events associated with bone marrow 
	4/30/1998	Sponsor and Address	transplantation.
	Marketing Exclusivity 	Vernon Knight, M.D.
	Baylor College of Medicine, Dept. of Molecular Phy
	One Baylor Plaza
	Houston TX  77030 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal doxorubicin hydrochloride
	Trade Name:
	Sarcodoxome	Orphan Designation:
	Treatment of soft tissue sarcomas
	Designation 
	12/27/2006	Sponsor and Address
	Marketing Exclusivity 	GP-Pharm SA
	Pol. Ind. Els Vinyets els Fogars n 2,
	Quinti de Mediona
	Barcelona    
	SPAIN
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Liposomal N-Acetylglucosminyl-N-Acetylmuramly-L-
	Ala-D-isoGln-L-Ala -gylcerolidpalmitoyl
	Trade Name:
	ImmTher	Orphan Designation:
	Treatment of osteosarcoma. 
	Designation 
	6/10/1998	Sponsor and Address
	Marketing Exclusivity 	Endorex Corp.
	900 North Shore Drive
	Lake Bluff IL  60044 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal N-Acetylglucosminyl-N-Acetylmuramly-L-
	Ala-D-isoGln-L-Ala -gylcerolidpalmitoyl
	Trade Name:
	ImmTher	Orphan Designation:
	Treatment of Ewing's sarcoma. 
	Designation 
	6/10/1998	Sponsor and Address
	Marketing Exclusivity 	Endorex Corp.
	900 North Shore Drive
	Lake Bluff IL  60044 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal nystatin
	Trade Name:
	Nyotran	Orphan Designation:
	Treatment of invasive fungal infections.
	Designation 
	6/13/2000	Sponsor and Address
	Marketing Exclusivity 	The University of Texas 
	M.D. Anderson Cancer Center
	Unit 038
	Houston TX  77030 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	liposomal p-ethoxy growth receptor bound protein-2 
	antisense product
	Trade Name:
	Orphan Designation:
	Treatment of chronic myelogenous leukemia
	Designation 
	12/5/2003	Sponsor and Address
	Marketing Exclusivity 	Bio-Path, Inc.
	3293 Harrison Blvd., Suite 230
	Ogden UT  84403 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal prostaglandin E1 injection
	Trade Name:
	Orphan Designation:
	Treatment of acute respiratory distress syndrome.
	Designation 
	4/25/1996	Sponsor and Address
	Marketing Exclusivity 	Liposome Company, Inc.
	One Research Way
	Princeton NJ  08540 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Liposomal-cis-bis-neodecanoato-trans-R,R-1,2-
	diaminocyclohexane-Pt (II)
	Trade Name:
	Aroplatin	Orphan Designation:
	Treatment of malignant mesothelioma.
	Designation 
	9/1/1999	Sponsor and Address
	Marketing Exclusivity 	Antigenics Incorporated
	3 Forbes Road
	Lexington MA  02421 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposome encapsulated recombinant interleukin-2
	Trade Name:
	Orphan Designation:
	Treatment of brain and CNS tumors.
	Designation 
	11/25/1991	Sponsor and Address
	Marketing Exclusivity 	Biomira, Inc.
	2011 - 94th Street
	Edmonston, AB
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposome encapsulated recombinant interleukin-2
	Trade Name:
	Orphan Designation:
	Treatment of cancers of the kidney and renal pelvis
	Designation 
	6/20/1994	Sponsor and Address
	Marketing Exclusivity 	Oncothyreon Canada, Inc.
	2011 - 94th Street NW
	Edmonton
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lisofylline
	Trade Name:
	Orphan Designation:
	Treatment of patients undergoing induction therapy for acute myeloid 
	leukemia.  
	Designation 
	6/10/1999	Sponsor and Address
	Marketing Exclusivity 	Cell Therapeutics, Inc.
	201 Elliot Avenue West201
	Suite 400
	Seattle WA  98119 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-leucovorin
	Trade Name:
	Isovorin	Orphan Designation:
	For use in combination chemotherapy with the approved agent 5-
	fluorouracil in the  palliative treatment of metastatic adenocarcinoma of 
	Designation 	the colon and rectum.
	12/18/1990	Sponsor and Address
	Marketing Exclusivity 	Spectrum Pharmaceuticals, Inc.
	157 Technology Drive
	Irvine CA  92618 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Lodoxamide tromethamine	Treatment of ocular disorders referred to by the terms vernal 
	keratoconjunctivitis, vernal conjunctivitis, vernal keratitis.
	Trade Name:
	Alomide Ophthalmic Solution	Orphan Designation:
	Treatment of vernal keratoconjunctivitis.
	Designation 
	10/16/1991	Sponsor and Address
	Marketing Exclusivity 	Alcon Laboratories, Inc.
	9/23/1993	6201 South Freeway
	Fort Worth TX  76134 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Loxoribine
	Trade Name:
	Orphan Designation:
	Treatment of common variable immunodeficiency.
	Designation 
	2/24/1992	Sponsor and Address
	Marketing Exclusivity 	R. W. Johnson Pharmaceutical Research Institute
	Route 202, P.O. Box 300
	Raritan NJ  08869 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-threonine
	Trade Name:
	Orphan Designation:
	Treatment of spasticity associated with familial spastic paraparesis.
	Designation 
	7/24/1992	Sponsor and Address
	Marketing Exclusivity 	Interneuron Pharmaceuticals, Inc.
	99 Hayden Ave., Suite 200
	Lexington MA  02421-7966
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-threonine
	Trade Name:
	Threostat	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis.
	Designation 
	2/6/1989	Sponsor and Address
	Marketing Exclusivity 	Tyson And Associates
	12832 Chadron Avenue
	Hawthorne CA  90250 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	L-threonyl-L-prolyl-L-prolyl-L-threonine
	Trade Name:
	Orphan Designation:
	Treatment of neuropathic pain associated with spinal cord injury
	Designation 
	4/26/2005	Sponsor and Address
	Marketing Exclusivity 	Nyxis Neurotherapies, Inc.
	1801 Maple Avenue
	Suite 4300
	Evanston IL  60201 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	L-tyrosine-L-serine-L-leucine
	Trade Name:
	CMS-024	Orphan Designation:
	Treatment of hepatocellular carcinoma.
	Designation 
	9/10/2004	Sponsor and Address
	Marketing Exclusivity 	CMS Peptides Patent Holding Company Limited
	Unit 2106, 21st Floor, Island Place Tower
	510 King's Rd
	North Point    
	HONG KONG
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lucinactant
	Trade Name:
	Surfaxin	Orphan Designation:
	Prevention of bronchopulmonary dysplasia in premature infants
	Designation 
	5/23/2006	Sponsor and Address
	Marketing Exclusivity 	Discovery Laboratories, Inc
	2600 Kelly Road
	Warrington PA  18976 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lucinactant
	Trade Name:
	Surfaxin	Orphan Designation:
	Treatment of bronchopulmonary dysplasia in premature infants.
	Designation 
	10/21/2005	Sponsor and Address
	Marketing Exclusivity 	Discovery Labsoratories, Inc.
	2600 Kelly Road
	Warrington PA  18976 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lucinactant
	Trade Name:
	Surfaxin	Orphan Designation:
	Treatment of meconium aspiration syndrome in newborn infants
	Designation 
	7/30/1996	Sponsor and Address
	Marketing Exclusivity 	Discovery Laboratories, Inc.
	2600 Kelly Road
	Warrington PA  18976 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lucinactant
	Trade Name:
	Surfaxin	Orphan Designation:
	Treatment of acute respiratory distress syndrome in adults.
	Designation 
	7/17/1995	Sponsor and Address
	Marketing Exclusivity 	Discovery Laboratories, Inc.
	2600 Kelly Road
	Warrington PA  18976 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Lucinactant
	Trade Name:
	Surfaxin	Orphan Designation:
	Treatment of respiratory distress syndrome in premature infants.
	Designation 
	10/18/1995	Sponsor and Address
	Marketing Exclusivity 	Discovery Laboratories, Inc.
	2600 Kelly Road
	Warrington PA  18976 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lysine acetylsalicylate injectable
	Trade Name:
	Orphan Designation:
	Treatment of pain and fever secondary to sickle cell disease crisis.
	Designation 
	8/1/1989	Sponsor and Address
	Marketing Exclusivity 	G.D. Searle & Company
	4901 Searle Parkway
	Skokie IL  60077 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mafenide acetate solution
	Trade Name:
	Sulfamylon solution	Orphan Designation:
	For use as an adjunctive topical antimicrobial agent to control bacterial 
	infection when used under moist dressings over meshed autografts on 
	Designation 	excised burn wounds. 
	7/18/1990	Sponsor and Address
	Marketing Exclusivity 	Mylan Laboratories, Inc.
	6/5/1998	781 Chestnut Ridge Road
	P.O. Box 4310
	Morgantown WV  26504-4310
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mafosfamide
	Trade Name:
	Orphan Designation:
	Treatment of neoplastic meningitis
	Designation 
	1/21/2003	Sponsor and Address
	Marketing Exclusivity 	Baxter Healthcare Corporation
	Route 120 & Wilson Road
	Round Lake IL  60073-0490
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mammalian target of rapamcyin (mTOR) inhibitor
	Trade Name:
	Orphan Designation:
	Treatment of soft tissue sarcoma
	Designation 
	8/12/2005	Sponsor and Address
	Marketing Exclusivity 	ARIAD Pharmaceuticals, Inc
	26 Landsdowne Street
	Cambridge MA  02139-4234
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Manganese superoxide dismutase mimetic
	Trade Name:
	Orphan Designation:
	Prevention of radiation- or chemotherapy-induced oral mucositis in cancer 
	patients
	Designation 
	2/27/2008	Sponsor and Address
	Marketing Exclusivity 	ActivBiotics, Inc.
	110 Hartwell Avenue
	Lexington MA  02421 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mannitol 
	Trade Name:
	Bronchitol	Orphan Designation:
	For use to facilitate clearance of mucus in patients with bronchiectasis and 
	in patients with cystic fibrosis at risk for bronchiectasis
	Designation 
	2/11/2005	Sponsor and Address
	Marketing Exclusivity 	Pharmaxis Ltd.
	10 Rodborough Rd.
	NSW 2086    
	 
	AUSTRALIA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	mannopentaose phosphate sulfate
	Trade Name:
	Orphan Designation:
	Treatment of high-risk Stage II, Stage III, and Stage IV melanoma
	Designation 
	4/27/2004	Sponsor and Address
	Marketing Exclusivity 	Progen Industries Limited
	P. O. Box 28
	Richlands 4077    
	 
	AUSTRALIA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	maribavir
	Trade Name:
	Orphan Designation:
	Prevention of cytomegalovirus viremia and disease in the populations at 
	risk.
	Designation 
	2/1/2007	Sponsor and Address
	Marketing Exclusivity 	ViroPharma Inc.
	397 Eagleview Blvd.
	Exton PA  19341 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Marijuana
	Trade Name:
	Orphan Designation:
	Treatment of HIV-associated wasting syndrome.
	Designation 
	5/25/1999	Sponsor and Address
	Marketing Exclusivity 	Multidisciplinary Association for Psychedelic Studies, Inc.
	3 Francis St.
	Belmont MA  02478 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Matrix metalloproteinase inhibitor
	Trade Name:
	Galardin	Orphan Designation:
	Treatment of corneal ulcers.
	Designation 
	12/5/1991	Sponsor and Address
	Marketing Exclusivity 	Glycomed, Inc
	860 Atlantic Avenue
	Alameda CA  94501 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	MaxAdFVIII
	Trade Name:
	Orphan Designation:
	Treatment of  Hemophilia A
	Designation 
	3/3/2003	Sponsor and Address
	Marketing Exclusivity 	GenStar Therapeutics Corporation
	10865 Altman Row
	Suite 200
	San Diego CA  92121-1113
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mazindol
	Trade Name:
	Sanorex	Orphan Designation:
	Treatment of Duchenne muscular dystrophy.
	Designation 
	12/8/1986	Sponsor and Address
	Marketing Exclusivity 	Collipp, Platon J. M.D.
	176 Memorial Drive
	Jesup GA  31545 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mecamylamine
	Trade Name:
	Inversine	Orphan Designation:
	Treatment of Tourette's syndrome.
	Designation 
	10/14/1998	Sponsor and Address
	Marketing Exclusivity 	Targacept, Inc.
	200 East First St.
	Suite 300
	Winston-Salem NC  27101-4165
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	mecasermin 
	Trade Name:
	Iplex	Orphan Designation:
	Treatment of myotonic dystrophy
	Designation 
	12/3/2007	Sponsor and Address
	Marketing Exclusivity 	Insmed, Inc.
	8720 Stony Point Parkway
	Richmond VA  23235 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Mecasermin
	Trade Name:
	Myotrophin	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis.
	Designation 
	8/5/1991	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	41 Moores Road
	P. O. Box 4011
	Frazer PA  19355 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mecasermin	Long-term treatment of growth failure in children with severe primary IGF-1 
	deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who 
	have developed neutralizing antibodies to growth hormone.  
	Trade Name:
	Increlex	Orphan Designation:
	Treatment of growth hormone insensitivity syndrome.
	Designation 
	12/12/1995	Sponsor and Address
	Marketing Exclusivity 	Tercica, Inc.
	8/30/2005	2000 Sierra Point Parkway
	Suite 400
	Brisbane CA  94005 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	mecasermin rinfabate	Treatment of growth failure in children with severe primary IGF-1 deficiency
	 (Primary IGFD) or with growth hormone (GH) gene deletion who have 
	developed neutralizing antibodies to growth hormone
	Trade Name:
	iPLEX	Orphan Designation:
	Treatment of growth hormone insensitivity syndrome (GHIS)
	Designation 
	5/17/2002	Sponsor and Address
	Marketing Exclusivity 	Insmed, Inc.
	12/12/2005	8720 Stony Point Parkway
	Suite 200
	Richmond VA  23235 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	meclorethamine or nitrogen mustard
	Trade Name:
	Orphan Designation:
	Treatment of mycosis fungoides.
	Designation 
	8/12/2004	Sponsor and Address
	Marketing Exclusivity 	Yaupon Therapeutics, Inc.
	259 Radnor Chester Road
	Radnor PA  19087 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	MEDI-522
	Trade Name:
	Vitaxin	Orphan Designation:
	For the treatment of metastatic melanoma
	Designation 
	4/14/2004	Sponsor and Address
	Marketing Exclusivity 	MedImmune, LLC 
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Medroxyprogesterone acetate
	Trade Name:
	Hematrol	Orphan Designation:
	Treatment of immune thrombocytopenic purpura.
	Designation 
	2/22/2001	Sponsor and Address
	Marketing Exclusivity 	ZaBeCor Pharmaceutical Company, LLC
	821 Westview Street
	Philadelphia PA  19119 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mefloquine HCl
	Trade Name:
	Mephaquin	Orphan Designation:
	Prevention of chloroquine-resistant Falciparum malaria.
	Designation 
	7/22/1987	Sponsor and Address
	Marketing Exclusivity 	Mepha AG
	4143 Dornach
	POSTFASH 137
	    
	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mefloquine HCl
	Trade Name:
	Mephaquin	Orphan Designation:
	Treatment of chloroquine-resistant Falciparummalaria.
	Designation 
	7/22/1987	Sponsor and Address
	Marketing Exclusivity 	Mepha AG
	4143 Dornach
	POSTFASH 137
	    
	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mefloquine HCl
	Trade Name:
	Lariam	Orphan Designation:
	Prophylaxis of Plasmodium falciparum malaria which is resistant to other 
	available drugs.
	Designation 
	4/13/1988	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	5/2/1989	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mefloquine HCl
	Trade Name:
	Lariam	Orphan Designation:
	Treatment of acute malaria due to Plasmodium falciparum and 
	Plasmodium vivax.
	Designation 
	4/13/1988	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	5/2/1989	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Megestrol acetate	Treatment of anorexia, cachexia, or an unexplained significant weight loss 
	in patients with a diagnosis of acquired immune deficiency syndrome.
	Trade Name:
	Megace	Orphan Designation:
	Treatment of patients with anorexia, cachexia, or significant weight loss 
	(=/>10% of baseline body weight) and confirmed diagnosis of AIDS.
	Designation 
	4/13/1988	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	9/10/1993	2400 West Lloyd Expressway
	Evansville IN  47721 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Melanoma autologous dendritic cell vaccine
	Trade Name:
	Orphan Designation:
	Treatment of stage IIIb through IV metastatic melanoma
	Designation 
	9/6/2006	Sponsor and Address
	Marketing Exclusivity 	Hoag Memorial Hospital Presbyterian
	Hoag Cancer Center Cell Biology Laboratory
	Building 41
	Newport Beach CA  92658 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Melanoma cell vaccine
	Trade Name:
	Canvaxin	Orphan Designation:
	Treatment of invasive melanoma.
	Designation 
	10/13/1994	Sponsor and Address
	Marketing Exclusivity 	CancerVax Corporation
	2110 Rutherford Road
	Carlsbad CA  92008 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Melanoma peptide vaccine
	Trade Name:
	Orphan Designation:
	Treatment of HLA-A2+ patients with stage  IIB, IIC, III, and IV malignant 
	melanoma
	Designation 
	3/29/2005	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Research Inst
	5 Research Parkway
	P. O. Box 5100
	Wallingford CT  06492 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Melanoma vaccine
	Trade Name:
	Melacine	Orphan Designation:
	Treatment of stage III - IV melanoma.
	Designation 
	12/20/1989	Sponsor and Address
	Marketing Exclusivity 	Ribi ImmunoChem Research, Inc.
	533 Old Corvallis Road
	Hamilton MT  59840 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Melatonin
	Trade Name:
	Circadin	Orphan Designation:
	Treatment of non-24-hour sleep-wake disorder in blind individuals without 
	light perception
	Designation 
	7/9/2004	Sponsor and Address
	Marketing Exclusivity 	Neurim Pharmaceuticals, Ltd.
	8 Hanechoshet St.
	Tel-Aviv    
	 
	ISRAEL
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Melatonin
	Trade Name:
	Orphan Designation:
	Treatment of circadian rhythm sleep disorders in blind people with no light 
	perception.
	Designation 
	11/15/1993	Sponsor and Address
	Marketing Exclusivity 	Sack, Robert, M.D.
	Oregon Health Sciences University
	3181 S.W. Sam Jackson Park Road
	Portland OR  97201 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	meloxicam	For relief of the signs and symptoms of pauciarticular or polyarticular course
	 Juvenile Rheumatoid Arthritis in patients 2 years of age or older
	Trade Name:
	Mobic	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis
	Designation 
	11/22/2002	Sponsor and Address
	Marketing Exclusivity 	Boehringer Ingelheim Pharmaceuticals, Inc.
	8/11/2005	900 Ridgebury Road
	P. O. Box 368
	Ridgefield CT  06877-0368
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Melphalan
	Trade Name:
	Alkeran for Injection	Orphan Designation:
	For use in hyperthermic regional limb perfusion to treat metastatic 
	melanoma of the extremity.
	Designation 
	3/3/1992	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Research and Development
	5 Moore Drive
	PO Box 13398
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Melphalan	For the palliative treatment of patients with multiple myeloma for whom 
	oral melphalan is not appropriate.
	Trade Name:
	Alkeran For Injection	Orphan Designation:
	Treatment of patients with multiple myeloma for whom oral therapy is 
	inappropriate.
	Designation 
	2/24/1992	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	11/18/1992	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	mepivacaine
	Trade Name:
	Orphan Designation:
	Treatment of postherpetic neuralgia
	Designation 
	1/8/2007	Sponsor and Address
	Marketing Exclusivity 	Cinergen, LLC
	146 Medinah Drive
	Blue Bell PA  19422-3212
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mepivacaine
	Trade Name:
	Orphan Designation:
	Treatment of painful HIV-associated neuropathy
	Designation 
	10/18/2006	Sponsor and Address
	Marketing Exclusivity 	Cinergen
	146 Medinah Drive
	Blue Bell PA  19422-3212
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	mepolizumab
	Trade Name:
	Orphan Designation:
	For first-line treatment in patients with hypereosinophilic syndrome
	Designation 
	5/28/2004	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline Pharmaceuticals
	P.O. Box 7929
	Philadelphia PA  19101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Meropenem
	Trade Name:
	Merrem IV	Orphan Designation:
	Management of acute pulmonary exacerbations, in cystic fibrosis patients, 
	due to respiratory tract infection with susceptible organisms.
	Designation 
	4/27/2000	Sponsor and Address
	Marketing Exclusivity 	AstraZeneca Pharmaceuticals
	1800 Concord Pike
	PO Box 15437
	Wilmington DE  19850-5437
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	mesalamine; 5-aminosalicylic acid
	Trade Name:
	Lialda	Orphan Designation:
	Treatment of active, mild to moderate ulcerative colitis in children 5 to 17 
	years 
	Designation 
	2/27/2008	Sponsor and Address
	Marketing Exclusivity 	Shire
	725 Chesterbrook Blvd.
	Wayne PA  19087-5637
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Mesna
	Trade Name:
	Orphan Designation:
	Inhibition of the urotoxic effects induced by oxazaphosphorine compounds 
	such as cyclophosphamide.
	Designation 
	12/16/1987	Sponsor and Address
	Marketing Exclusivity 	Asta Medica , Inc.
	890 East St.
	Tewksbury MA  01876-1496
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mesna
	Trade Name:
	Mesnex	Orphan Designation:
	For use as a prophylactic agent in reducing the incidence of ifosfamide-
	induced hemorrhagic cystitis.
	Designation 
	11/14/1985	Sponsor and Address
	Marketing Exclusivity 	Degussa Corporation
	12/30/1988	65 Challenger Road
	Ridgefield Park NJ  07660 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Methionine/L-methionine
	Trade Name:
	Orphan Designation:
	Treatment of AIDS myelopathy.
	Designation 
	8/21/1996	Sponsor and Address
	Marketing Exclusivity 	Genopia USA, Inc.
	90 Gold Street, 6N
	New York NY  10038 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	methotrexate
	Trade Name:
	Rheumatrex	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis.
	Designation 
	8/23/1993	Sponsor and Address
	Marketing Exclusivity 	Wyeth-Ayerst Laboratories
	P.O. Box 8299
	Philadelphia PA  19101-8299
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Methotrexate sodium	For the use of high dose methotrexate with leucovorin rescue in patients 
	with non-metastatic osteosarcoma who have undergone surgical resection 
	or amputation for the primary tumor.
	Trade Name:
	Methotrexate	Orphan Designation:
	Treatment of osteogenic sarcoma.
	Designation 
	10/21/1985	Sponsor and Address
	Marketing Exclusivity 	Lederle Laboratories
	4/7/1988	Division of American Cyanamid Company
	401 N. Middletown Road
	Pearl River NY  10965 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Methotrexate with laurocapram
	Trade Name:
	Methotrexate/azone	Orphan Designation:
	Topical treatment of mycosis fungoides.
	Designation 
	10/15/1990	Sponsor and Address
	Marketing Exclusivity 	Echo Therapeutics, Ltd.
	10 Forge Parkway
	Franklin MA  02038 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Methoxsalen
	Trade Name:
	Uvadex	Orphan Designation:
	For use in conjunction with the UVAR photopheresis system to treat graft 
	versus host disease.
	Designation 
	10/14/1998	Sponsor and Address
	Marketing Exclusivity 	Therakos, Inc.
	437 Creamery Way
	Exton PA  19431 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	metreleptin
	Trade Name:
	Orphan Designation:
	Treatment of metabolic disorders secondary to lipodystrophy
	Designation 
	8/22/2001	Sponsor and Address
	Marketing Exclusivity 	Amylin Pharmaceuticals, Inc.
	9360 Towne Centre Drive
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	metreleptin
	Trade Name:
	Orphan Designation:
	Treatment of leptin deficiency secondary to generalized
	lipodystrophy and partial familial lipodystrophy
	Designation 
	8/22/2001	Sponsor and Address
	Marketing Exclusivity 	Amylin Pharmaceuticals, Inc.
	9360 Towne Center Drive
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Metronidazole
	Trade Name:
	Metrogel	Orphan Designation:
	Treatment of perioral dermatitis.
	Designation 
	10/24/1991	Sponsor and Address
	Marketing Exclusivity 	Galderma Laboratories, Inc.
	P.O. Box 331329
	Fort Worth TX  76163 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Metronidazole (topical)
	Trade Name:
	Flagyl	Orphan Designation:
	Treatment of grade III and IV, anaerobically infected, decubitus ulcers.
	Designation 
	11/24/1987	Sponsor and Address
	Marketing Exclusivity 	Searle
	4901 Searle Parkway
	Skokie IL  60077 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Metronidazole (topical)
	Trade Name:
	Metrogel	Orphan Designation:
	Treatment of acne rosacea.
	Designation 
	10/22/1987	Sponsor and Address
	Marketing Exclusivity 	Galderma Laboratories, Inc.
	11/22/1988	P.O. Box 331329
	Fort Worth TX  76163 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Metronidazole 10% ointment
	Trade Name:
	Orphan Designation:
	Topical treatment of active perianal Crohn's disease
	Designation 
	11/8/2007	Sponsor and Address
	Marketing Exclusivity 	S.L.A. Pharma (UK) Ltd
	Elite House
	Leavesden  
	Watford WD25 7SA    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mibefradil 
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer
	Designation 
	6/15/2007	Sponsor and Address
	Marketing Exclusivity 	Tau Therapeutics, LLC
	2988 Cove Trace
	Charlottesville VA  22911 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Microbubble contrast agent
	Trade Name:
	Filmix Neurosonographic Contrast Agent	Orphan Designation:
	Intraoperative aid in the identification and localization of intracranial 
	tumors.
	Designation 
	11/16/1990	Sponsor and Address
	Marketing Exclusivity 	Cav-Con, Inc.
	55 Knollwood Road
	Farmington CT  06032 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Microvesiculated modified glycosylated tissue factor
	Trade Name:
	Orphan Designation:
	Treatment of cutaneous bleeding episodes in patients with von Willebrand 
	disease.
	Designation 
	10/11/2007	Sponsor and Address
	Marketing Exclusivity 	Thrombotargets Corp.
	2530 Meridian Parkway
	Durham NC  27713 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Microvesiculated modified glycosylated tissue factor
	Trade Name:
	Orphan Designation:
	Treatment of non-life threatening, mild to severe bleeding episodes due to 
	cutaneous injuries or dental procedures in hemophiliac patients
	Designation 
	1/25/2007	Sponsor and Address
	Marketing Exclusivity 	Thrombotargets Corp.
	2530 Meridian Parkway
	Suite 3023
	Durham NC  27713 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Midazolam HCl 
	Trade Name:
	Orphan Designation:
	Treatment of bouts of increased seizure activity in selected refractory 
	patients with epilepsy who are on stable regimens of anti-epileptic drugs 
	Designation 	and who require intermittent use of midazolam
	5/8/2006	Sponsor and Address
	Marketing Exclusivity 	Schwarz Biosciences, Inc.
	8010 Arco Corporate Drive
	Raleigh NC  27617 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Midodrine HCl	Treatment of symptomatic orthostatic hypotension.
	Trade Name:
	Amatine	Orphan Designation:
	Treatment of patients with symptomatic orthostatic hypotension.
	Designation 
	12/5/1996	Sponsor and Address
	Marketing Exclusivity 	Schier Ridgewood          F.K.A. (Roberts Pharmaceutical Corp.)
	9/6/1996	Meridian Center III
	6 Industrial Way West
	Eatontown NJ  07724 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	mifamuritide
	Trade Name:
	Junovan	Orphan Designation:
	Treatment of osteosarcoma
	Designation 
	6/5/2001	Sponsor and Address
	Marketing Exclusivity 	Immuno-Designed Molecules
	9 Parker
	Irvine CA  92618-1605
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Mifepristone
	Trade Name:
	Orphan Designation:
	Treatment of Cushing's syndrome secondary to ectopic ACTH secretion
	Designation 
	2/7/2005	Sponsor and Address
	Marketing Exclusivity 	HRA Pharma
	19, rue Frederick Lmaitre
	75020 Paris    
	 
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	mifepristone
	Trade Name:
	Corlux	Orphan Designation:
	Treatment of the clinical manifestations of endogenous Cushing's 
	symdrome.
	Designation 
	7/5/2007	Sponsor and Address
	Marketing Exclusivity 	Corcept Therapeutics, Inc.
	149 Commonwealth Drive
	Menlo Park CA  94025 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	miglustat	Treatment of mild to moderate Type I Gaucher disease in adults for whom 
	enzyme replacement therapy is not a therapeutic option (e.g., due to 
	constraints such as allergy, hypersensitivity, or poor venous access). 
	Trade Name:
	Zavesca	Orphan Designation:
	Treatment of Gaucher disease.
	Designation 
	5/29/1998	Sponsor and Address
	Marketing Exclusivity 	Actelion  Pharmaceuticals Ltd
	7/31/2003	Gewerbestrasse 16
	CH - 4123 Allschwi
	    
	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	milatuzumab
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	3/10/2008	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	miltefosine
	Trade Name:
	Impavido	Orphan Designation:
	Treatment of leishmaniasis.
	Designation 
	10/10/2006	Sponsor and Address
	Marketing Exclusivity 	AEterna Zentaris GmbH
	Weismullerstrasse 50
	D-60314 Frankfurt
	    
	GERMANY
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Minocycline HCl
	Trade Name:
	Minocin Intravenous	Orphan Designation:
	Treatment of chronic malignant pleural effusion.
	Designation 
	6/19/1992	Sponsor and Address
	Marketing Exclusivity 	Lederle Laboratories Division
	Division of American Cyanamid Company
	401 N. Middletown Road
	Pearl River NY  10965 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Minocycline hydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of sarcoidosis
	Designation 
	3/28/2006	Sponsor and Address
	Marketing Exclusivity 	Autoimmunity Research Foundation
	Autoimmunity Research, Inc.
	Thousand Oaks CA  91360 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	misoprostol
	Trade Name:
	GyMiso	Orphan Designation:
	Treatment of intrauterine fetal death not accompanied by complete 
	expulsion of the products of conception in the second and third trimesters of
	Designation 	 pregnancy.
	1/10/2005	Sponsor and Address
	Marketing Exclusivity 	Gynuity Health Projects, LLC
	15 East 26th Street
	New York NY  10010 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mitoguazone
	Trade Name:
	apep	Orphan Designation:
	Treatment of diffuse non-Hodgkin's lymphoma, including AIDS-related 
	diffuse non-Hodgkin's lymphoma.
	Designation 
	3/18/1994	Sponsor and Address
	Marketing Exclusivity 	ILEX Oncology, Inc.
	4545 Horizon Hill Blvd.
	San Antonio TX  78229-2263
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mitolactol
	Trade Name:
	Orphan Designation:
	Treatment of invasive carcinoma of the uterine cervix
	Designation 
	1/23/1989	Sponsor and Address
	Marketing Exclusivity 	Biopharmaceutics, Inc.
	990 Station Road
	Bellport NY  11713 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Mitolactol
	Trade Name:
	Orphan Designation:
	As adjuvant therapy in the treatment of primary brain tumors.
	Designation 
	7/12/1995	Sponsor and Address
	Marketing Exclusivity 	Biopharmaceutics, Inc.
	990 Station Road
	Bellport NY  11713 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	mitomycin-C
	Trade Name:
	Trabomycin	Orphan Designation:
	Treatment of refractory glaucoma as an adjunct to ab externo glaucoma 
	surgery.
	Designation 
	1/8/2008	Sponsor and Address
	Marketing Exclusivity 	Mobius Therapeutics, Inc.
	743 Spirit 40 Park Drive
	Chesterfield MO  63005 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mitomycin-C
	Trade Name:
	Orphan Designation:
	Treatment of refractory glaucoma as an adjunct to ab externo glaucoma 
	surgery.
	Designation 
	8/20/1993	Sponsor and Address
	Marketing Exclusivity 	IOP Inc.
	3100 Airway Avenue, Suite 106
	Costa Mesa CA  92626 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mitoxantrone	In combination with corticosteroids as initial chemotherapy for the 
	treatment of patients with pain related to advanced hormone-refractory 
	prostate cancer.
	Trade Name:
	Novantrone	Orphan Designation:
	Treatment of hormone refractory prostate cancer.
	Designation 
	8/21/1996	Sponsor and Address
	Marketing Exclusivity 	Serono
	11/13/1996	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mitoxantrone	Reducing neurologic disability and/or the frequency of clinical relapses in 
	patients with secondary (chronic) progressive, progressive relapsing, or 
	worsening relapsing-remitting multiple sclerosis (i.e., patients whose 
	Trade Name:	neurologic status is significantly adnormal between relapses).
	Novantrone	Orphan Designation:
	Treatment of secondary-progressive multiple sclerosis.
	Designation 
	8/13/1999	Sponsor and Address
	Marketing Exclusivity 	Serono, Inc.
	10/13/2000	One Technoloogy Place
	Rockland MA  02370 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Mitoxantrone	Reducing neurologic disability and/or the frequency of clinical relapses in 
	patients with secondary (chronic) progressive, progressive relapsing, or 
	worsening relapsing-remitting multiple sclerosis (i.e., patients whose 
	Trade Name:	neurologic status is significantly adnormal between relapses).
	Novantrone	Orphan Designation:
	Treatment of progressive-relapsing multiple sclerosis.
	Designation 
	8/13/1999	Sponsor and Address
	Marketing Exclusivity 	Serono, Inc.
	10/13/2000	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mitoxantrone HCl
	Trade Name:
	Novantrone	Orphan Designation:
	Treatment of acute myelogenous leukemia, also referred to as acute 
	nonlymphocytic leukemia.
	Designation 
	7/13/1987	Sponsor and Address
	Marketing Exclusivity 	Lederle Laboratories
	12/23/1987	Division of American Cyanamid Company
	401 N. Middletown Road
	Pearl River NY  10965 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	MN14 monoclonal antibody to carcinoembryonic 
	antigen
	Trade Name:
	Cea-Cide	Orphan Designation:
	Treatment of small cell lung cancer 
	Designation 
	9/18/1998	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Rd.
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	MN14 monoclonal antibody to carcinoembryonic 
	antigen
	Trade Name:
	Cea-Cide	Orphan Designation:
	Treatment of pancreatic cancer.
	Designation 
	11/24/1998	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Modafinil	Improve wakefulness in patients with excessive daytime sleepiness 
	associated with narcolepsy.
	Trade Name:
	Provigil	Orphan Designation:
	Treatment of excessive daytime sleepiness in narcolepsy.
	Designation 
	3/15/1993	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	12/24/1998	145 Brandywine Parkway
	West Chester PA  19380 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Molgramostim
	Trade Name:
	Leucomax	Orphan Designation:
	Treatment of AIDS patients with neutropenia due to the disease, AZTor 
	ganciclovir.
	Designation 
	1/24/1989	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Molgramostim
	Trade Name:
	Leucomax	Orphan Designation:
	Treatment of aplastic anemia.
	Designation 
	9/25/1989	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	monarsen
	Trade Name:
	Orphan Designation:
	Treatment of Myasthenia Gravis
	Designation 
	11/14/2003	Sponsor and Address
	Marketing Exclusivity 	Medica Venture Partners
	Ackerstein Towers, Bldg B, 10th Floor
	ISRAEL
	    
	ISRAEL
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Monoclonal Ab(murine) anti-idiotype melanoma-
	associated antigen
	Trade Name:
	Melimmune	Orphan Designation:
	Treatment of invasive cutaneous melanoma.
	Designation 
	9/19/1994	Sponsor and Address
	Marketing Exclusivity 	IDEC Pharmaceuticals Corporation
	3030 Callan Road
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Monoclonal antibodies (murine or human) to B-cell 
	lymphoma
	Trade Name:
	Orphan Designation:
	Treatment of B-cell lymphoma.
	Designation 
	5/6/1986	Sponsor and Address
	Marketing Exclusivity 	IDEC Pharmaceuticals Corporation
	11011 Torreyana Road
	San Diego CA  92121 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Monoclonal antibody 17-1a
	Trade Name:
	Panorex	Orphan Designation:
	Treatment of pancreatic cancer.
	Designation 
	4/4/1988	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	244 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Monoclonal antibody for immunization against lupus
	 nephritis
	Trade Name:
	Orphan Designation:
	Treatment of lupus nephritis.
	Designation 
	1/7/1993	Sponsor and Address
	Marketing Exclusivity 	VivoRx Autoimmune, Inc.
	2825 Santa Monica Blvd., Suite 200
	Santa Monica CA  90404 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Monoclonal antibody to cytomegalovirus (human)
	Trade Name:
	Orphan Designation:
	Treatment of cytomegalovirus retinitis in patients with AIDS.
	Designation 
	11/15/1991	Sponsor and Address
	Marketing Exclusivity 	Protein Design Labs, Inc.
	2375 Garcia Avenue
	Mountain View CA  94043 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Monoclonal antibody to cytomegalovirus (human)
	Trade Name:
	Orphan Designation:
	Prophylaxis of cytomegalovirus disease in patients undergoing solid organ 
	transplantation.
	Designation 
	9/13/1991	Sponsor and Address
	Marketing Exclusivity 	Protein Design Labs, Inc.
	2375 Garcia Avenue
	Mountain View CA  94043 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Monoclonal antibody to hepatitis B virus (human)
	Trade Name:
	Orphan Designation:
	Prophylaxis of hepatitis B reinfection in patients undergoing liver 
	transplantation secondary to end-stage chronic hepatitis B infection.
	Designation 
	6/17/1991	Sponsor and Address
	Marketing Exclusivity 	Protein Design Labs, Inc.
	34801 Campus Dr.
	Fremont CA  94555 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Monoclonal antibody-B43.13
	Trade Name:
	Ovarex MAb-B43.13	Orphan Designation:
	Treatment of epithelial ovarian cancer.
	Designation 
	11/25/1996	Sponsor and Address
	Marketing Exclusivity 	ViRexx Medical Corporation
	8223 Roper Road
	Edmonton
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Monoclonal antiendotoxin antibody XMMEn-0e5
	Trade Name:
	Orphan Designation:
	Treatment of patients with gram-negative sepsis which has progressed to 
	shock.
	Designation 
	11/4/1985	Sponsor and Address
	Marketing Exclusivity 	Pfizer, Inc.
	235 East 42nd Street
	New York NY  10017 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Monolaurin
	Trade Name:
	Glylorin	Orphan Designation:
	Treatment of congenital primary ichthyosis.
	Designation 
	4/29/1993	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	5 Moore Drive
	PO Box 13398
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Monooctanoin
	Trade Name:
	Moctanin	Orphan Designation:
	For dissolution of cholesterol gallstones retained in the common bile duct.
	Designation 
	5/30/1984	Sponsor and Address
	Marketing Exclusivity 	Ethitek Pharmaceuticals, Inc.
	10/31/1985	7855 Gross Point Road, Unit L
	Skokie IL  60077 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Morphine sulfate concentrate (preservative free)	For intrathecal or epidural infusion in the treatment of tractable chronic 
	pain. It was developed for use in continuous microinfusion devices and may
	 require dilution before use as directed.
	Trade Name:
	Infumorph	Orphan Designation:
	For use in microinfusion devices for intraspinal administration in the 
	treatment of intractable chronic pain.
	Designation 
	7/12/1990	Sponsor and Address
	Marketing Exclusivity 	Elkins-Sinn, Inc.
	7/19/1991	2 Esterbrook Lane
	Cherry Hill NJ  08003 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	motexafin gadolinium
	Trade Name:
	Xcytrin	Orphan Designation:
	For use in conjunction with whole brain radiation for the treatment of brain 
	metastases arising from solid tumors
	Designation 
	1/27/2003	Sponsor and Address
	Marketing Exclusivity 	Pharmacyclics, Inc.
	999 East Arques Avenue
	Sunnyvale CA  94085-4521
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	MTC-DOX for Injection
	Trade Name:
	Orphan Designation:
	Treatment of hepatocellular carcinoma
	Designation 
	1/3/2001	Sponsor and Address
	Marketing Exclusivity 	FeRx Incorporated
	4330 La Jolla Village Drive
	Suite #250
	San Diego CA  92122 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mucoid exopolysaccharide Pseudomonas 
	hyperimmune globulin
	Trade Name:
	MEP IGIV	Orphan Designation:
	Treatment of pulmonary infections due to Pseudomonas aeruginosa in 
	patients with cystic fibrosis.
	Designation 
	1/9/1991	Sponsor and Address
	Marketing Exclusivity 	North American Biologicals, Inc.
	12280 Wilkins Avenue
	Rockville MD  20852 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mucoid exopolysaccharide Pseudomonas 
	hyperimmune globulin
	Trade Name:
	MEP IGIV	Orphan Designation:
	Prevention of pulmonary infections due to Pseudomonas aeruginosa in 
	patients with cystic fibrosis.
	Designation 
	11/7/1990	Sponsor and Address
	Marketing Exclusivity 	North American Biologicals, Inc.
	12280 Wilkins Avenue
	Rockville MD  20852 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Multi-ligand somatostatin analogue
	Trade Name:
	Orphan Designation:
	Treatment of patients with functional gastroenteropancreatic (GEP) 
	neuroendocrine tumors (specifically, carcinoid, insulinoma, gastrinoma, 
	Designation 	somastatinoma, GRFoma, VIPoma and glucagonoma.
	7/27/2004	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Multi-vitamin infusion (neonatal formula)
	Trade Name:
	Orphan Designation:
	For establishment and maintenance of total parenteral nutrition in very low 
	birth weight infants.
	Designation 
	12/12/1989	Sponsor and Address
	Marketing Exclusivity 	Astra Pharmaceuticals, L.P.
	725 Chesterbrook Blvd.
	Wayne PA  19087-5677
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	multi-vitiam infusion without vitamin K	Prevention of vitamin deficiency and thrombormbolic complications in 
	people receiving home parenteral nutrition who also receive warfarin-type 
	anticoagulant therapy
	Trade Name:
	M.V.I.-12	Orphan Designation:
	Prevention of vitamin deficiency and thromboembolic complications
	in people receiving home parenteral nutrition and warfarin-type 
	Designation 	anticoagulant therapy
	3/8/2004	Sponsor and Address
	Marketing Exclusivity 	Mayne Pharma (USA) Inc.
	9/9/2004	Mack-Cali Centre II
	Second Floor
	Paramus NJ  07652 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Murine MAb (Lym-1) and Iodine 131-I radiolabeled 
	murine MAb (Lym-1) to human B-cell lymphoma
	Trade Name:
	Oncolym	Orphan Designation:
	Treatment of B-cell non-Hodgkin's lymphoma.  
	Designation 
	11/27/1998	Sponsor and Address
	Marketing Exclusivity 	Peregrine Pharmaceuticals, Inc.
	14272 Franklin Ave.
	Suite 100
	Tustin CA  92780 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Murine MAb to polymorphic epithelial mucin, human
	 milk fat globule 1
	Trade Name:
	Theragyn	Orphan Designation:
	Adjuvant treatment of ovarian cancer.
	Designation 
	3/22/1999	Sponsor and Address
	Marketing Exclusivity 	Antisoma plc
	West Africa House
	Hanger Lane Ealing
	London W5 3QR    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mx-dnG1 or Rexin-G retroviral vector
	Trade Name:
	REXIN-G	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	8/15/2003	Sponsor and Address
	Marketing Exclusivity 	Epeius Biotechnologies Corporation
	345 Pioneer Drive, 1803W
	Glendale CA  91203 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Mycobacterium avium sensitin RS-10
	Trade Name:
	Orphan Designation:
	For use in the diagnosis of invasive Mycobacterium avium disease in 
	immunocompetent individuals.
	Designation 
	10/11/1995	Sponsor and Address
	Marketing Exclusivity 	Statens Seruminstitut
	5 Artillerivej
	DK-2300 Copenhagen S
	    
	SWEDEN
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mycophenolate mofetil
	Trade Name:
	CellCept	Orphan Designation:
	Treatment of pemphigus vulgaris
	Designation 
	5/26/2006	Sponsor and Address
	Marketing Exclusivity 	Hoffman-La Roche, Inc.
	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Myelin
	Trade Name:
	Orphan Designation:
	Treatment of multiple sclerosis.
	Designation 
	6/27/1991	Sponsor and Address
	Marketing Exclusivity 	AutoImmune, Inc.
	128 Spring Street
	Lexington MA  02173 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	myo-inositol
	Trade Name:
	Orphan Designation:
	Prevention of retinopathy of prematurity in preterm infants at risk for 
	developing retinopathy of prematurity
	Designation 
	4/7/2005	Sponsor and Address
	Marketing Exclusivity 	Abbott Nutrition
	Abbott Laboratories
	625 Cleveland Ave.
	Columbus OH  43215-1724
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	myristoylated recombinant SCR1-3 of human 
	complement reseptor type I
	Trade Name:
	APT070	Orphan Designation:
	Prevention of delayed graft function in solid organ transplant
	Designation 
	5/21/2003	Sponsor and Address
	Marketing Exclusivity 	Inflazyme Pharmaceuticals, Ltd.
	5600 Parkwood Way
	Suite 425
	    
	CANADA
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	N-((methyl-diazacyclohexyl-methylbenzamide)-
	asaphenyl-aminothiopyrrole) mesylate
	Trade Name:
	Orphan Designation:
	Treatment of malignant gastrointestinal stromal tumors.
	Designation 
	4/20/2005	Sponsor and Address
	Marketing Exclusivity 	AB Science
	3, avenue George V

	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-(2,2,2-trifluoroethyl)-9-[4-[4-[[[4'-
	(trifluoromethyl)[1,1'biphenyl]-2-yl]carbonyl]amino]-1-
	piperidinyl]butyl]-9H-fluorene-9-carboxamide, 
	methane-sulfonate salt
	Trade Name:
	Orphan Designation:
	Treatment of homozygous familial hypercholesterolemia
	Designation 
	10/23/2007	Sponsor and Address
	Marketing Exclusivity 	Aegerion Pharmaceuticals, Inc.
	Center Pointe IV
	Suite 304
	Bridgewater NJ  08807 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-(2,3-dihydro-3,3-dimethyl-1H-indol-6-yl)-2-[(4-
	pyridinylmethyl)amino]-3-pyridinecarboxamide, 
	phosphate (1:2)
	Trade Name:
	Orphan Designation:
	Treatment of gastrointestinal stromal tumors
	Designation 
	1/13/2005	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	One Amgen Center Drive
	Thousand Oaks CA  91320-1799
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-
	oxoquinoline-3-carboxamide
	Trade Name:
	Orphan Designation:
	Treatment of patients with cystic fibrosis.
	Designation 
	12/20/2006	Sponsor and Address
	Marketing Exclusivity 	Vertex Pharmaceuticals, Inc.
	130 Waverly St.
	Cambridge MA  02139-4242
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-
	ylamino)-methyl] benzamide dihydrobromide
	Trade Name:
	Orphan Designation:
	Treatment of Hodgkin's lymphoma
	Designation 
	8/8/2007	Sponsor and Address
	Marketing Exclusivity 	Pharmion Corporation
	2525 - 28th Street
	Boulder CO  80301 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-
	ylamino)-methyl] benzamide dihydrobromide
	Trade Name:
	Orphan Designation:
	Treatment of acute myeloid leukemia
	Designation 
	2/1/2008	Sponsor and Address
	Marketing Exclusivity 	Pharmion Corporation
	2525 - 28th Street
	Boulder CO  80301 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-(methyl-diazacyclohexyl-methylbenzamide)-
	azaphenyl-aminothiopyrrole) mesylate
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma.
	Designation 
	10/17/2005	Sponsor and Address
	Marketing Exclusivity 	AB Science
	3, avenue George V

	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-[2-[(4-hydroxyphenyl)amino]-3-pyridinyl]-4-
	methoxybenzenesulfonamide
	Trade Name:
	Orphan Designation:
	Treatment of neuroblastoma
	Designation 
	9/30/2004	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	Pharmaceuticals Products Division
	D-491, AP30-1E
	Abbott Park IL  60064-6157
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-[3-(4',5'-bipyrimidin-2-ylamino)-4-methylphenyl]-4-
	{[(3S)-3-(dimethylamino)pyrrolidin-1-yl]methyl}-3-
	(trifluoromethyl)benzamide
	Trade Name:
	Orphan Designation:
	Treatment of Philadelphia chromosome-positive chronic myelogenous 
	leukemia.
	Designation 
	12/27/2006	Sponsor and Address
	Marketing Exclusivity 	Innovive Pharmaceuticals
	555 Madison Avenue
	New York NY  10022 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-[4-(3-amino-1H-indazol-4-yl)phenyl]-N1-(2-fluoro-5-
	methylphenyl) urea
	Trade Name:
	Orphan Designation:
	Treatment of acute myelogenous leukemia
	Designation 
	10/23/2007	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	Global Pharmaceuticals Research & Development
	200 Abbott Park Road
	Abbott Park IL  60064-6157
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	N-[4-(3-amino1H-indazol-4-yl)phenyl]-N1-(2-fluoro-5-
	methylphenyl)urea
	Trade Name:
	Orphan Designation:
	Treatment of hepatocellular carcinoma
	Designation 
	5/23/2007	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	Global Pharmaceuticals Research & Development
	200 Abbott Park Road
	Abbott Park IL  60064-6157
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-[4-(4-amino-2-ethyl-1H-imidazo[4,5-c]quinolin-1-
	yl)butyl]methanesulfonamide
	Trade Name:
	Orphan Designation:
	Treatment of stages IIB-IV melanoma
	Designation 
	8/13/2004	Sponsor and Address
	Marketing Exclusivity 	Coley Pharmaceuticals Group, Inc.
	93 Worcester Street
	Suite 101
	Wellesley MA  02481 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-[4-(4-amino-2-ethyl-lH-imidazo[4,5-c]quinolin-1-
	yl)butyl]methanesulfonamide
	Trade Name:
	Orphan Designation:
	Treatment of cutaneous T-cell lymphoma
	Designation 
	3/24/2006	Sponsor and Address
	Marketing Exclusivity 	Pfizer, Inc.
	50 Pequot Avenue
	6025-A3106
	New London CT  06320 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-[4-bromo-2-(1H-1,2,3,4-tetrazol-5-yl)phenyl]-N'-[3,5-
	bis(trifluoromethyl)phenyl]urea
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell disease
	Designation 
	5/13/2002	Sponsor and Address
	Marketing Exclusivity 	NeuroSearch A/S
	93 Pederstrupvej
	DK-2750 Ballerup
	    
	DENMARK
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N2'-Deacetyl-N2'-[4-methyl-4-(oxobuthyldithio)-1-
	oxopentyl]-maytansine-chimerized anti-CD138 IgG4 
	Monoclonal Antibody
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	2/27/2008	Sponsor and Address
	Marketing Exclusivity 	Biotest Pharmaceuticals Corporation
	5800 Park of Commerce Blvd., NW
	Boca Raton FL  33487 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	nabumetone
	Trade Name:
	Orphan Designation:
	For treatment of pediatric juvenile rheumatoid arthritis.
	Designation 
	5/5/2008	Sponsor and Address
	Marketing Exclusivity 	Cook Pharma
	109 Graylyn Drive
	Chapel Hill NC  27516 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-acetylcysteinate Lysine
	Trade Name:
	Nacystelyn Dry Powder Inhaler	Orphan Designation:
	For the management of cystic fibrosis
	Designation 
	12/27/2000	Sponsor and Address
	Marketing Exclusivity 	Galephar Pharmaceutical Research, Inc.
	Road 198, No. 100 km. 14.7
	Juncos Industrial Park
	Juncos   00777-3873
	PUERTO RICO
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-acetylcysteine
	Trade Name:
	Orphan Designation:
	Treatment of acute liver failure
	Designation 
	9/9/2002	Sponsor and Address
	Marketing Exclusivity 	William M. Lee, MD, FACP
	University of Texas Southwestern Medical Center at
	5323 Harry Hines Blvd
	Dallas TX  75390-9151
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-acetylgalactosamine-4-sulfatase, recombinant 	For patients with mucopolysaccharidosis VI.  Galsulfase has been shown to 
	human	improve walking and stair-climbing capacity.
	Trade Name:
	Naglazyme	Orphan Designation:
	Treatment of mucopolysaccharidosis Type VI (Maroteaux-Lamy syndrome).
	Designation 
	2/17/1999	Sponsor and Address
	Marketing Exclusivity 	BioMarin Pharmaceutical, Inc.
	5/31/2005	105 Digital Drive
	Novato CA  94949-5608
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-acetyl-glucosamine thiazoline 
	Trade Name:
	Orphan Designation:
	Treatment of adult Tay-Sachs disease
	Designation 
	2/6/2006	Sponsor and Address
	Marketing Exclusivity 	ExSAR Corporation
	11 Deer Park Drive
	Monmouth Junction NJ  08852 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	N-acetylprocainamide
	Trade Name:
	Napa	Orphan Designation:
	To lower the defibrillation energy requirement sufficiently to allow 
	automatic implantable cardioverter defibrillator therapy in those patients 
	Designation 	who could otherwise not use the device.
	3/23/1990	Sponsor and Address
	Marketing Exclusivity 	Medco Research, Inc.
	8455 Beverly Blvd.
	Suite 308
	Los Angeles CA  90048 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-acetyl-procainamide
	Trade Name:
	Orphan Designation:
	Prevention of life-threatening ventricular arrhythmias in patients with 
	documented procainamide-induced lupus.
	Designation 
	12/10/1996	Sponsor and Address
	Marketing Exclusivity 	NAPA of the Bahamas
	3560 Pennsylvania Avenue, Suite 7
	Dubuque IA  52002 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-acetyl-sarcosyl-glycyl-L-valyl-D-alloisoleucyl-L-
	threonyl-L-norvalyl-L-isoleucyl-L-arginyl_L-
	prolylethylaminde acetate
	Trade Name:
	Orphan Designation:
	Treatment of soft tissue sarcoma
	Designation 
	12/9/2003	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	Pharmaceutical Products Division
	200 Abbott Park Road
	Abbott Park IL  60064 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-adamantanyl-N'-Geranyl-ethylenediamine
	Trade Name:
	Orphan Designation:
	Treatment of tuberculosis.
	Designation 
	10/16/2007	Sponsor and Address
	Marketing Exclusivity 	Sequella, Inc.
	9610 Medical Center Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nafarelin acetate	Treatment of central precocious puberty (gonadotropin-dependent 
	precocious puberty) in children of both sexes.
	Trade Name:
	Synarel Nasal Solution	Orphan Designation:
	Treatment of central precocious puberty.
	Designation 
	7/20/1988	Sponsor and Address
	Marketing Exclusivity 	Syntex (USA), Inc.
	2/26/1992	3401 Hillview Avenue
	Palo Alto CA  94303 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Naltrexone HCl
	Trade Name:
	Trexan	Orphan Designation:
	For blockade of the pharmacological effects of exogenously administered 
	opioids as an adjunct to the maintenance of the opioid-free state in 
	Designation 	detoxified formerly opioid-dependent individuals.
	3/11/1985	Sponsor and Address
	Marketing Exclusivity 	DuPont Pharmaceuticals
	11/30/1984	E.I. Du Pont De Nemours & Co.
	Wilmington DE  19880 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	natural human lymphoblastoid interferon-alpha
	Trade Name:
	Orphan Designation:
	Treatment of polycythemia vera
	Designation 
	11/18/2002	Sponsor and Address
	Marketing Exclusivity 	Amarillo Biosciences, Inc.
	4134 Business Park Drive
	Amarillo TX  79110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Natural human lymphoblastoid interferon-alpha
	Trade Name:
	Orphan Designation:
	Treatment of Behcet's disease.
	Designation 
	1/18/2000	Sponsor and Address
	Marketing Exclusivity 	Amarillo Biosciences, Inc.
	4134 Business Park Drive
	Amarillo TX  79110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Natural human lymphoblastoid interferon-alpha
	Trade Name:
	Orphan Designation:
	Treatment of papillomavirus warts in the oral cavity of HIV positive patients.
	Designation 
	8/10/2000	Sponsor and Address
	Marketing Exclusivity 	Amarillo Biosciences, Inc.
	4134 Business Park Drive
	Amarillo TX  79110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	NDROGE
	Trade Name:
	Orphan Designation:
	Treatment of postanoxic intention myoclonus.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	WATSON Laboratories, Inc.
	33 Ralph Avenue
	P.O. Box 30
	Copiaque NY  11726-0030
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Nebacumab
	Trade Name:
	Centoxin	Orphan Designation:
	Treatment of patients with gram-negative bacteremia which has progressed 
	to endotoxin shock.
	Designation 
	10/1/1986	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	200 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	nelarabine	Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell 
	lymphoblastic lymphoma whose disease has not responded to or has 
	relapsed following treatment with at least two chemotherapy regimens
	Trade Name:
	Arranon	Orphan Designation:
	Treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma
	Designation 
	8/10/2004	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline
	10/28/2005	One Franklin Plaza
	Phildelphia PA  19101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Neurotrophin-1
	Trade Name:
	Orphan Designation:
	Treatment of motor neuron disease/amyotrophic lateral sclerosis.
	Designation 
	9/13/1994	Sponsor and Address
	Marketing Exclusivity 	Ericsson, Arthur Dale, M.D.
	6560 Fannin, Scurlock Tower, Suite 720
	Houston TX  77303 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	NG-29
	Trade Name:
	Somatrel	Orphan Designation:
	Diagnostic measure of the capacity of the pituitary gland to release growth 
	hormone.
	Designation 
	8/8/1989	Sponsor and Address
	Marketing Exclusivity 	Ferring Laboratories, Inc.
	400 Rella Boulevard, Suite 201
	Suffern NY  10901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nifedipine
	Trade Name:
	Orphan Designation:
	Treatment of interstitial cystitis.
	Designation 
	6/13/1991	Sponsor and Address
	Marketing Exclusivity 	Fleischmann, Jonathan M.D.
	MetroHealth Medical Center
	3395 Scranton Road
	Cleveland OH  44109 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Nikkomycin Z
	Trade Name:
	Orphan Designation:
	Treatment of coccidioidomycosis
	Designation 
	2/14/2006	Sponsor and Address
	Marketing Exclusivity 	Valley Fever Center for Excellence (1-111 INF)
	University of Arizona
	Tucson AZ  85723 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	nilotinib
	Trade Name:
	Tasigna	Orphan Designation:
	Treatment of gastrointestinal stromal tumors.
	Designation 
	3/20/2007	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaeuticals Corporation
	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nilotinib	For the use for chronic phase (CP) and accelerated phase (AP) Philadelphia
	 chromosome positive chronic myelogenous leukemia  (CML) in adult 
	patients resistant to or intolerant to prior therapy that included 
	Trade Name:	GleevecÃÂ®(imatinib)
	Tasigna	Orphan Designation:
	Treatment of chronic myelogenous leukemia
	Designation 
	4/27/2006	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceutical Corporation
	10/29/2007	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nimotuzumab
	Trade Name:
	Orphan Designation:
	Treatment of glioma
	Designation 
	11/17/2004	Sponsor and Address
	Marketing Exclusivity 	YM Biosciences Inc.
	5045 Orbitor Drive
	Mississauga, Ontario L4W 4Y4
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	niprisan
	Trade Name:
	Hemoxin	Orphan Designation:
	Treatment of sickle cell disease
	Designation 
	8/15/2003	Sponsor and Address
	Marketing Exclusivity 	Xechem International, Inc.
	379 Thornall Road
	Edison NJ  08837 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	nitazoxanide
	Trade Name:
	Cryptaz	Orphan Designation:
	Treatment for intestinal amebiasis
	Designation 
	10/23/2001	Sponsor and Address
	Marketing Exclusivity 	Romark Laboratories, L.C.
	6200 Courtney Campbell Causeway
	Suite 880
	Tampa FL  33607 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	nitazoxanide	Treatment of diarrhea caused by Cryptosporidium parvum and Giardia 
	lamblia
	Trade Name:
	Alinia	Orphan Designation:
	Treatment of intestinal giardiasis
	Designation 
	2/14/2002	Sponsor and Address
	Marketing Exclusivity 	Romark Laboratories, L.C.
	11/22/2002	6200 Courtney Campbell Causeway
	Suite 880
	Tampa FL  33607 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nitazoxanide	Treatment of diarrhea caused by Cryptosporidium parvum and Giardia 
	lamblia
	Trade Name:
	Alinia	Orphan Designation:
	Treatment of cryptosporidiosis.
	Designation 
	12/12/1996	Sponsor and Address
	Marketing Exclusivity 	Romark Laboratories, L.C.
	11/22/2002	6200 Courtney Campbell Causeway
	Suite 880
	Tampa FL  33607 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nitisinone
	Trade Name:
	Orfadin	Orphan Designation:
	Treatment of alkaptonuria
	Designation 
	10/19/2001	Sponsor and Address
	Marketing Exclusivity 	Swedish Orphan AB
	Kungsgatan 37, 7th Floor
	SE-111 56
	    
	SWEDEN
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nitisinone	Adjunctive therapy to dietary  restriction of tyrosine and phenylalanine in 
	the treatment of hereditary tyrosinemia type 1
	Trade Name:
	Orfadin	Orphan Designation:
	Treatment of tyrosinemia type 1.
	Designation 
	5/16/1995	Sponsor and Address
	Marketing Exclusivity 	Swedish Orphan AB
	1/18/2002	Drottninggatan 98
	SE-111 60 Stockholm
	    
	SWEDEN
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Nitric oxide
	Trade Name:
	Orphan Designation:
	Diagnosis of sarcoidosis
	Designation 
	2/16/2005	Sponsor and Address
	Marketing Exclusivity 	SensorMedics Corporation
	22705 Savi Ranch Parkway
	Yorba Linda CA  92887-4645
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nitric oxide
	Trade Name:
	INOmax	Orphan Designation:
	To reduce the risk of chronic lung disease in premature neonates
	Designation 
	9/27/2004	Sponsor and Address
	Marketing Exclusivity 	INO Therapeutics
	6 Route 173
	Clinton NJ  08809 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nitric oxide	In conjunction with ventilatory support and other appropriate agents, in the 
	treatment of term and near-term (>34 weeks) neonates with hypoxic 
	respiratory failure associated with clinical or echocardiographic evidence of 
	Trade Name:	pulmonary hypertension, where it improves oxygenation and reduces the 
	need for extracorporeal membrane oxygenation.
	INOmax	Orphan Designation:
	Treatment of persistent pulmonary hypertension in the newborn.
	Designation 
	6/22/1993	Sponsor and Address
	Marketing Exclusivity 	INO Therapeutics, Inc.
	12/23/1999	54 Old Highway 22
	Clinton NJ  08809 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nitric oxide
	Trade Name:
	Orphan Designation:
	Treatment of acute respiratory distress syndrome in adults.
	Designation 
	7/10/1995	Sponsor and Address
	Marketing Exclusivity 	INO Therapeutics, Inc.
	54 Old Highway 22
	Clinton NJ  08809 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nitroprusside
	Trade Name:
	Orphan Designation:
	Treatment and prevention of cerebral vasospasm following subarachnoid 
	hemorrhage.
	Designation 
	2/21/2001	Sponsor and Address
	Marketing Exclusivity 	Thomas, MD, Jeffrey Evan
	Thomas Jefferson University and Wills Neurosensory
	834 Walnut Street, Suite 650
	Philadelphia PA  19107-5102
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	N-malonyl-bis(N'-methyl-N'-thiobenzoylhydrazide)
	Trade Name:
	Orphan Designation:
	Treatment of metastatic melanoma in combination with paclitaxel 
	Designation 
	12/18/2007	Sponsor and Address
	Marketing Exclusivity 	Synta Pharmaceuticals Corporation
	45 Hartwell Ave.
	Lexington MA  02421 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-Methyl-2-[3-[((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-
	ylsulfanyl]benzamide
	Trade Name:
	Axitinib	Orphan Designation:
	Treatment of follicular, medullary and anaplastic thyroid carcinoma and 
	metastatic or locally advanced papillary thyroid cancer.
	Designation 
	5/4/2007	Sponsor and Address
	Marketing Exclusivity 	Pfizer, Inc.
	La Jolla Laboratories
	10646 Science Center Drive
	San Diego CA  92121 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Novel Acting Thrombolytic (NAT)
	Trade Name:
	Orphan Designation:
	Treatment of peripheral arterial occlusion (PAO)
	Designation 
	1/26/2001	Sponsor and Address
	Marketing Exclusivity 	Nuvelo, Inc. Inc.
	201 Industrial Road
	Suite 310
	San Carlos CA  94070- 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nucleic acid aptamer binding to tumor cell nucleolin
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic cancer
	Designation 
	8/17/2004	Sponsor and Address
	Marketing Exclusivity 	Antisoma Research Ltd.
	Hanger Lane
	Ealing
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nucleic acid aptamer binding to tumor cell nucleon
	Trade Name:
	Orphan Designation:
	Treatment of renal cell carcinoma
	Designation 
	7/28/2005	Sponsor and Address
	Marketing Exclusivity 	Antisoma Research Ltd.
	Hanger Lane
	Ealing, London
	    
	UNITED KINGDOM
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	NZ-1002	Enzyme replacement therapy in patients with all subtypes of 
	Mucopolysaccharidosis I.
	Trade Name:
	Orphan Designation:
	Enzyme replacement therapy in patients with all subtypes of 
	Mucopolysaccharidosis I.
	Designation 
	4/11/2001	Sponsor and Address
	Marketing Exclusivity 	Novazyme Pharmaceuticals, Inc.
	800 Research Parkway
	Suite 200
	Oklahoma City OK  73104 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Obatoclax mesylate
	Trade Name:
	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	10/8/2004	Sponsor and Address
	Marketing Exclusivity 	Gemin X, Inc.
	5 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Obatoclax mesylate
	Trade Name:
	Orphan Designation:
	Treatment of myelodysplastic syndrome
	Designation 
	11/6/2006	Sponsor and Address
	Marketing Exclusivity 	Gemin X, Inc.
	5 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Obatoclax mesylate
	Trade Name:
	Orphan Designation:
	Treatment of myelofibrosis
	Designation 
	12/1/2006	Sponsor and Address
	Marketing Exclusivity 	Gemin X, Inc.
	400 Chesterfield Pkwy.
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	oblimersen
	Trade Name:
	Genasense	Orphan Designation:
	Treatment of advanced malignant melanoma (Stages II,III, IV).
	Designation 
	7/31/2000	Sponsor and Address
	Marketing Exclusivity 	Genta, Inc.
	Two Connell Drive
	Berkeley Heights NJ  07922 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Octreotide	Supression of severe diarrhea and flushing associated with malignant 
	carcinoid syndrome.
	Trade Name:
	Sandostatin LAR	Orphan Designation:
	Treatment of severe diarrhea and flushing associated with malignant 
	carcinoid tumors.
	Designation 
	8/24/1998	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	11/25/1998	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Octreotide	Reduction of growth hormone and IGF-1 (somatomedin C) in acromegaly.
	Trade Name:
	Sandostatin LAR	Orphan Designation:
	Treatment of acromegaly.
	Designation 
	8/24/1998	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	11/25/1998	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Octreotide	Treatment of profuse watery diarrhea associated with VIPoma.
	Trade Name:
	Sandostatin LAR	Orphan Designation:
	Treatment of diarrhea associated with vasoactive intestinal peptide tumors 
	(VIPoma).
	Designation 
	8/24/1998	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	11/25/1998	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ofloxacin	Treatment of bacterial corneal ulcers.
	Trade Name:
	Ocuflox Ophthalmic Solution	Orphan Designation:
	Treatment of bacterial corneal ulcers.
	Designation 
	4/18/1991	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	5/22/1996	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92713 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	oglufanide disodium
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer
	Designation 
	9/24/2001	Sponsor and Address
	Marketing Exclusivity 	Implicit Bioscience Pty Ltd
	P. O. Box 2072
	Toowong Business Center
	    
	AUSTRALIA
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	OM 401
	Trade Name:
	Drepanol	Orphan Designation:
	Prophylactic treatment of sickle cell disease.
	Designation 
	10/24/1991	Sponsor and Address
	Marketing Exclusivity 	Omex International, Inc.
	6001 Savoy, Suite 110
	Houston TX  77036 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Omacetaxine mepesuccinate
	Trade Name:
	Orphan Designation:
	Treatment of chronic myelogenous leukemia
	Designation 
	3/10/2006	Sponsor and Address
	Marketing Exclusivity 	ChemGenex Pharmaceuticals, Inc.
	3715 Haven Avenue
	Menlo Park CA  94025 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Omega-3 (n-3) polyunsaturated fatty acid with all 
	double bonds in the cis configuration
	Trade Name:
	Orphan Designation:
	Prevention of organ graft rejection.
	Designation 
	11/22/1995	Sponsor and Address
	Marketing Exclusivity 	Research Triangle Pharmaceuticals
	4364 South Alston Avenue
	Durham NC  27713 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Omega-3 (n-3) polyunsaturated fatty acids
	Trade Name:
	Omacor	Orphan Designation:
	Treatment of IgA nephropathy.
	Designation 
	5/4/2000	Sponsor and Address
	Marketing Exclusivity 	Pronova Biocare, AS
	PO Box 420 
	1327 Lysaker
	    
	NORWAY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Omegaven emulsion
	Trade Name:
	Omegaven	Orphan Designation:
	Treatment of parenteral nutrition-associated liver disease
	Designation 
	2/27/2008	Sponsor and Address
	Marketing Exclusivity 	Fresenius Kabi Deutschland GmbH
	Daimlerstrasse 16

	GERMANY
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Oncorad Ov103
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	4/24/1990	Sponsor and Address
	Marketing Exclusivity 	Cytogen Corporation
	600 College Road East
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Oprelvekin
	Trade Name:
	Neumega	Orphan Designation:
	Prevention of severe chemotherapy-induced thrombocytopenia. 
	Designation 
	12/17/1996	Sponsor and Address
	Marketing Exclusivity 	Genetics Institute, Inc.
	11/25/1997	87 Cambridge Park Drive
	Cambridge MA  02140 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	oral unfractionated heparin
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell disease
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	TRF Technologies, Inc.
	863 Mitten Road, Suite 101
	Burlingame CA  94010 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Orgotein for injection
	Trade Name:
	Orphan Designation:
	Treatment of familial amyotrophic lateral sclerosis associated with a 
	mutation of the gene (on chromosome 21q) for copper, zinc superoxide 
	Designation 	dismutase.
	12/22/1994	Sponsor and Address
	Marketing Exclusivity 	Oxis International, Inc.
	6040 N. Cutter Circle, Suite 317
	Portland OR  97217-3935
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ortezomib	Treatment of multiple myeloma patients who have received at least two 
	prior therapies and have demonstrated disease progression on the last 
	therapy
	Trade Name:
	Velcade	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	1/15/2003	Sponsor and Address
	Marketing Exclusivity 	Millennium Pharmaceuticals, Inc.
	5/13/2003	40 Landsdowne Street
	Cambridge MA  02139 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Oxaliplatin
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	10/6/1992	Sponsor and Address
	Marketing Exclusivity 	Debio Pharm S.A.
	Rue des Terreaux 17
	CH-1000
	    
	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Oxalobacter formigenes
	Trade Name:
	Orphan Designation:
	Treatment of primary hyperoxaluria
	Designation 
	3/29/2006	Sponsor and Address
	Marketing Exclusivity 	OxThera, Inc.
	13709 Progress Blvd. #17
	Alachua FL  32615 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Oxandrolone
	Trade Name:
	Oxandrin	Orphan Designation:
	Treatment of short stature associated with Turner's syndrome.
	Designation 
	7/5/1990	Sponsor and Address
	Marketing Exclusivity 	Bio-Technology General Corp.
	70 Wood Avenue, South
	Iselin NJ  08830 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Oxandrolone
	Trade Name:
	Orphan Designation:
	Treatment of constitutional delay of growth and puberty.
	Designation 
	10/5/1990	Sponsor and Address
	Marketing Exclusivity 	Bio-Technology General Corp.
	70 Wood Avenue, South
	Iselin NJ  08830 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Oxandrolone
	Trade Name:
	Oxandrin	Orphan Designation:
	Treatment of patients with Duchenne's muscular dystrophy and Becker's 
	muscular dystrophy.
	Designation 
	4/22/1997	Sponsor and Address
	Marketing Exclusivity 	Savient Pharmaceuticals, Inc.
	One Tower Center Boulevard, 12th floor
	East Brunswick NJ  08816 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Oxandrolone
	Trade Name:
	Oxandrin	Orphan Designation:
	Adjunctive therapy for AIDS patients suffering from HIV-wasting syndrome.
	Designation 
	9/6/1991	Sponsor and Address
	Marketing Exclusivity 	Bio-Technology General Corp.
	One Tower Center Boulevard, 12 th floor
	East Brunswick NJ  08816 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Oxandrolone
	Trade Name:
	Hepandrin	Orphan Designation:
	Treatment of moderate/severe acute alcoholic hepatitis in the presence of 
	moderate protein calorie malnutrition.
	Designation 
	3/18/1994	Sponsor and Address
	Marketing Exclusivity 	Bio-Technology General Corp.
	70 Wood Avenue South
	Iselin NJ  08830 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	oxybate	Treatment of excessive daytime sleepiness in patients with narcolepsy
	Trade Name:
	Xyrem	Orphan Designation:
	Treatment of narcolepsy
	Designation 
	11/7/1994	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals
	11/18/2005	3180 Porter Drive
	Palo Alto  CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	oxybate	Treatment of cataplexy associated with narcolepsy.
	Trade Name:
	 Xyrem	Orphan Designation:
	Treatment of narcolepsy.
	Designation 
	11/7/1994	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals
	7/17/2002	3180 Porter Drive
	Palo Alto  CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Oxymorphone
	Trade Name:
	Numorphan H.P.	Orphan Designation:
	For relief of severe intractable pain in narcotic-tolerant patients.
	Designation 
	3/19/1985	Sponsor and Address
	Marketing Exclusivity 	DuPont Merck Pharmaceutical Company
	P.O. Box 80027
	Wilmington DE  19880 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Oxypurinol
	Trade Name:
	Orphan Designation:
	Treatment of hyperuricemia in patients intolerant to allopurinol.
	Designation 
	11/9/1998	Sponsor and Address
	Marketing Exclusivity 	Cardiome Pharma Corp.
	3650 Westbrook Mall
	Vancouver, B.C.
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	p1-(uridine 5'-)-p4-(2'-deoxycytidine 5'-) 
	tetraphosphate, tetrasodium salt
	Trade Name:
	Orphan Designation:
	For the treatment of cystic fibrosis
	Designation 
	3/7/2001	Sponsor and Address
	Marketing Exclusivity 	Inspire Pharmaceuticals, Inc.
	4222 Emperor Blvd.
	Suite 470
	Durham NC  27703 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	P1, P4-Di(uridine 5'-tetraphosphate), tetrasodium salt
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis.  
	Designation 
	10/27/1998	Sponsor and Address
	Marketing Exclusivity 	Inspire Pharmaceuticals, Inc.
	4222 Emperor Blvd., Suite 470
	Durham NC  27703 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Paclitaxel	For the second line treatment of AIDS-related Kaposi's sarcoma.
	Trade Name:
	Taxol	Orphan Designation:
	Treatment of AIDS-related Kaposi's sarcoma.
	Designation 
	3/25/1997	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	8/4/1997	5 Research Parkway
	P.O. Box 5100
	Wallingford CT  06492-7660
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Paclitaxel
	Trade Name:
	Paxene	Orphan Designation:
	Treatment of AIDS-related Kaposi's sarcoma.
	Designation 
	4/15/1997	Sponsor and Address
	Marketing Exclusivity 	Baker Norton Pharmaceuticals, Inc.
	4400 Biscayne Boulevard
	Miami FL  33137 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	paclitaxel aqueous gel
	Trade Name:
	OncoGel	Orphan Designation:
	Treatment of esophageal cancer
	Designation 
	2/1/2008	Sponsor and Address
	Marketing Exclusivity 	Protherics, Inc.
	5214 Maryland Way 
	Brentwood TN  37027 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pafuramidine maleate
	Trade Name:
	Orphan Designation:
	Treatment of human African trypanosomiasis (sleeping sickness)
	Designation 
	8/31/2007	Sponsor and Address
	Marketing Exclusivity 	Immtech Pharmaceuticals, Inc.
	150 Fairway Drive
	Vernon Hills IL  60061 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pafuramidine maleate
	Trade Name:
	Orphan Designation:
	Treatment of malaria
	Designation 
	5/14/2007	Sponsor and Address
	Marketing Exclusivity 	Immtech Pharmaceuticsl, Inc.
	150 Fairway Drive
	Vernon Hills IL  60061 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	pafuramidine maleate
	Trade Name:
	Orphan Designation:
	Treatment of pneumocystis jiroveci pneuomina.
	Designation 
	11/17/2006	Sponsor and Address
	Marketing Exclusivity 	Immtech Pharmaceuticals, Inc.
	150 Fairway Drive 
	Suite 150
	Vernon Hills IL  60061 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Palifosfamide
	Trade Name:
	Orphan Designation:
	Treatment of soft tissue sarcomas.
	Designation 
	5/5/2008	Sponsor and Address
	Marketing Exclusivity 	Ziopharm Oncology, Inc.
	One First Avenue, Parris Building 34
	Boston MA  02129 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Panobinostat
	Trade Name:
	Faridak	Orphan Designation:
	Treatment of cutaneous T-cell lymphoma
	Designation 
	9/26/2007	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Papain, trypsin, and chymotrypsin
	Trade Name:
	Wobe-Mugos	Orphan Designation:
	Treatment of multiple myeloma.
	Designation 
	12/21/1998	Sponsor and Address
	Marketing Exclusivity 	Marlyn Nutraceuticals, Inc.
	14851 N. Scottsdale Rd.
	Scottsdale AZ  85254 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	parathyroid hormone
	Trade Name:
	Orphan Designation:
	Treatment of hypoparathyroidism.
	Designation 
	8/31/2007	Sponsor and Address
	Marketing Exclusivity 	NPS Pharmaceuticals, Inc.
	300 Interpace Parkway
	Parsippany NJ  07054 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	paromomycin sulfate/gentamicin sulfate
	Trade Name:
	Orphan Designation:
	Treatment of non-complicated Old World cutaneous leishmaniasis
	Designation 
	1/18/2008	Sponsor and Address
	Marketing Exclusivity 	Office of the Surgeon General
	Department of the Army
	1430 Veteran's Drive
	Ft. Detrick MD  21702 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Parvovirus B19 (recombinant VP1 and VP2; 
	S.frugiperda cells) vaccine
	Trade Name:
	MEDI-491	Orphan Designation:
	Prevention of transient aplastic crisis in patients with sickle cell anemia.  
	Designation 
	5/7/1999	Sponsor and Address
	Marketing Exclusivity 	MedImmune, Inc.
	35 West Watkins Mill Rd.
	Gaithersburg MD  20878 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Patul-end
	Trade Name:
	Orphan Designation:
	Treatment of patulous eustachian tube.
	
	Designation 	
	2/18/1997	
	 
	Sponsor and Address
	Marketing Exclusivity 	Ear Foundation
	2420 Castillo Street, Suite 100
	Santa Barbara CA  93105 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Patupilone
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	10/4/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceutical Corporation
	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pegademase bovine
	Trade Name:
	Adagen	Orphan Designation:
	For enzyme replacement therapy for ADA deficiency in patients with severe 
	combined immunodeficiency.
	Designation 
	5/29/1984	Sponsor and Address
	Marketing Exclusivity 	Enzon, Inc.
	3/21/1990	20 Kingsbridge Road
	Piscataway NJ  08854 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pegaspargase	Combination chemotherapy for the treatment of patients with acute 
	lymphoblastic leukemia who are hypersensitive to native forms of L-
	asparaginase.
	Trade Name:
	Oncaspar	Orphan Designation:
	Treatment of acute lymphocytic leukemia.
	Designation 
	10/20/1989	Sponsor and Address
	Marketing Exclusivity 	Enzon, Inc.
	2/1/1994	20 Kingsbridge Road
	Piscataway NJ  08854 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	PEG-glucocerebrosidase
	Trade Name:
	Lysodase	Orphan Designation:
	For use as chronic enzyme replacement therapy in patients with Gaucher's 
	disease who are deficient in glucocerebrosidase.
	Designation 
	12/9/1992	Sponsor and Address
	Marketing Exclusivity 	National Institute of Mental Health, NIH
	49 Convent Dr. MSC4405
	Bldg. 49, Room B1EE16
	Bethesda MD  20892-4405
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Peginterferon alfa-2a
	Trade Name:
	PEGASYS	Orphan Designation:
	Treatment of chronic myelogenous leukemia.
	Designation 
	9/30/1999	Sponsor and Address
	Marketing Exclusivity 	Hoffman-La Roche Inc.
	340 Kingsland St.
	Nutley NJ  07110-1199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Peginterferon alfa-2a
	Trade Name:
	PEGASYS	Orphan Designation:
	Treatment of renal cell carcinoma.
	Designation 
	7/13/1998	Sponsor and Address
	Marketing Exclusivity 	Hoffman-La Roche Inc.
	340 Kingsland St.
	Nutley NJ  07110-1199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	peginterferon alfa-2b
	Trade Name:
	PegIntron	Orphan Designation:
	Treatment of malignant melanoma stages IIb through IV. 
	Designation 
	4/9/2008	Sponsor and Address
	Marketing Exclusivity 	Schering-Plough Corporation
	2000 Galloping Hill Road
	Kenilworth NJ  07933-0530
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	PEG-interleukin-2
	Trade Name:
	Orphan Designation:
	Treatment of primary immunodeficiencies associated with T-cell defects.
	Designation 
	2/1/1990	Sponsor and Address
	Marketing Exclusivity 	Chiron Corporation
	4560 Horton Street
	Emeryville CA  94608 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pegvisomant	Treatment of acromegaly in patients who have had an inadequate 
	response to surgery and/or radiation therapy and/or other medical therapies,
	 or for whom these therapies are not appropriate
	Trade Name:
	Somavert	Orphan Designation:
	Treatment of acromegaly.
	Designation 
	6/24/1997	Sponsor and Address
	Marketing Exclusivity 	Sensus Corporation
	3/25/2003	Suite 430,
	98 San Jacinto Boulevard
	Austin TX  78701 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Pegylated arginine deiminase
	Trade Name:
	Melanocid	Orphan Designation:
	Treatment of invasive malignant melanoma.
	Designation 
	4/12/1999	Sponsor and Address
	Marketing Exclusivity 	Polaris Pharmaceuticals, Inc.
	A Polaris Group Company
	Suite 106
	San Diego CA  92121 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pegylated arginine deiminase
	Trade Name:
	Hepacid	Orphan Designation:
	Treatment of hepatocellular carcinoma.
	Designation 
	3/26/1999	Sponsor and Address
	Marketing Exclusivity 	Polaris Pharmaceuticals, Inc.
	A Polaris Group Company
	6370 Nancy Ridge Drive
	San Diego CA  92121 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pegylated recombinant human megakaryocyte 
	growth and development factor
	Trade Name:
	MEGAGEN	Orphan Designation:
	For reducing the period of thrombocytopenia in patients undergoing 
	hematopoietic stem cell transplantation. 
	Designation 
	10/20/1997	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	One Amgen Center Dr.
	Thousand Oaks CA  91320-1789
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Peldesine
	Trade Name:
	Orphan Designation:
	Treatment of cutaneous T-cell lymphoma.
	Designation 
	10/5/1993	Sponsor and Address
	Marketing Exclusivity 	BioCryst Pharmaceuticals, Inc.
	2190 Parkway Lake Drive
	Birmingham AL  35244 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	pemetrexed disodium	Treatment of patients with malignant pleural mesothelioma whose disease 
	is either unresectable or who are otherwise not candidates for curative 
	surgery
	Trade Name:
	Alimta	Orphan Designation:
	Treatment of malignant pleural mesothelioma
	Designation 
	8/28/2001	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly and Company
	2/4/2004	Lilly Corporate Center
	Indianapolis IN  46285 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Pentamidine isethionate
	Trade Name:
	Nebupent	Orphan Designation:
	Prevention of Pneumocystis carinii pneumonia in patients at high risk of 
	developing this disease.
	Designation 
	1/12/1988	Sponsor and Address
	Marketing Exclusivity 	Fujisawa USA, Inc.
	6/15/1989	3 Parkway North Center
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentamidine isethionate
	Trade Name:
	Pentam 300	Orphan Designation:
	Treatment of Pneumocystis carinii pneumonia.
	Designation 
	2/28/1984	Sponsor and Address
	Marketing Exclusivity 	Fujisawa USA, Inc.
	10/16/1984	3 Parkway North Center
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentamidine isethionate
	Trade Name:
	Orphan Designation:
	Treatment of Pneumocystis carinii pneumonia.
	Designation 
	10/29/1984	Sponsor and Address
	Marketing Exclusivity 	Aventis Behring L.L.C.
	1020 First Avenue
	PO Box 61501
	King of Prussia PA  19406-0901
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentamidine isethionate (inhalation)
	Trade Name:
	Pneumopent	Orphan Designation:
	Prevention of Pneumocystis carinii pneumonia in patients at high risk of 
	developing this disease.
	Designation 
	10/5/1987	Sponsor and Address
	Marketing Exclusivity 	Fisons Corporation
	755 Jefferson Rd., P.O. Box 1710
	Rochester NY  14603 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentastarch
	Trade Name:
	Pentaspan	Orphan Designation:
	As an adjunct in leukapheresis to improve the harvesting and increase the 
	yield of leukocytes by centrifugal means.
	Designation 
	8/28/1985	Sponsor and Address
	Marketing Exclusivity 	Du Pont Pharmaceuticals
	5/19/1987	E.I. Du Pont De Nemours & Co.
	Wilmington DE  19898 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	pentetate trisodium
	Trade Name:
	diethylenetriaminepentaacetate	Orphan Designation:
	Treatment of patients with known or suspected internal contamination with 
	plutonium, americium, or curium.
	Designation 
	4/12/2004	Sponsor and Address
	Marketing Exclusivity 	Heyl Chemisch-Pharmazeutische Fabrik GMBH & Co. KG
	Goerzallee 253
	Fedderal of Republic of Germany
	    
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentosan polysulfate sodium	Relief of bladder pain or discomfort associated with interstitial cystitis.
	Trade Name:
	Elmiron	Orphan Designation:
	Treatment of interstitial cystitis.
	Designation 
	8/7/1985	Sponsor and Address
	Marketing Exclusivity 	Alza Corporation
	9/26/1996	950 Page Mill Rd.
	PO Box 10950
	Palo Alto CA  94303-0802
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentostatin
	Trade Name:
	Nipent	Orphan Designation:
	Treatment of patients with chronic lymphocytic leukemia.
	Designation 
	1/29/1991	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	4140 Dublin Blvd.
	Suite 200
	Dublin CA  94568 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentostatin
	Trade Name:
	Nipent	Orphan Designation:
	Treatment of peripheral T-cell lymphomas.  
	Designation 
	11/24/1999	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	4140 Dublin Blvd.
	Suite 200
	Dublin CA  94568 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentostatin
	Trade Name:
	Nipent	Orphan Designation:
	Treatment of cutaneous T-cell lymphoma.
	Designation 
	3/27/1998	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	4140 Dublin Blvd.
	Suite 200
	Dublin CA  94568 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Pentostatin for injection	Single agent treatment for adult patients with alpha-interferon-refractory 
	hairy cell leukemia.
	Trade Name:
	Nipent	Orphan Designation:
	Treatment of hairy cell leukemia.
	Designation 
	9/10/1987	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	10/11/1991	4140 Dublin Blvd.
	Suite 200
	Dublin CA  94568 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Peptide 144 TGF beta-1 inhibitor
	Trade Name:
	Orphan Designation:
	Treatment of systemic sclerosis
	Designation 
	4/27/2006	Sponsor and Address
	Marketing Exclusivity 	Digna Biotech, S.L.
	Avenida Carlos III el Noble
	Pamplona (Navarra)
	    
	SPAIN
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Peptide 144 TGF beta-1-inhibitor 
	Trade Name:
	Orphan Designation:
	Treatment of localized scleroderma
	Designation 
	4/26/2006	Sponsor and Address
	Marketing Exclusivity 	Digna Biotech, S.L.
	Avenida Carlos III el Noble, 36, 1 Dcha. 31003

	SPAIN
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Peptidomimetic analog of hexarelin
	Trade Name:
	Orphan Designation:
	Diagnosis of growth hormone deficiency
	Designation 
	5/14/2007	Sponsor and Address
	Marketing Exclusivity 	Ardana Bioscience Ltd.
	38 Melville Street
	Scotland
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Perflubron
	Trade Name:
	LiquiVent	Orphan Designation:
	Treatment of acute respiratory distress disease (ARDS) in adults
	Designation 
	4/26/2001	Sponsor and Address
	Marketing Exclusivity 	Alliance Pharmaceutical Corp.
	3040 Science Park Road
	San Diego CA  92191 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Perfosfamide
	Trade Name:
	Pergamid	Orphan Designation:
	For use in the ex-vivo treatment of autologous bone marrow and 
	subsequent reinfusion in patients with acute myelogenous leukemia, also 
	Designation 	referred to as acute nonlymphocytic leukemia.
	12/4/1989	Sponsor and Address
	Marketing Exclusivity 	Scios Nova, Inc.
	2450 Bayshore Parkway
	Mountain View CA  94043 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pergolide
	Trade Name:
	Permax	Orphan Designation:
	Treatment of Tourette's syndrome.
	Designation 
	11/20/1997	Sponsor and Address
	Marketing Exclusivity 	Sallee, Floyd R. M.D., Ph.D.
	Cincinnati Children's Hospital Medical Center
	3333 Burnet Ave.
	Cincinnati OH  45229-3039
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Phenylacetate
	Trade Name:
	Orphan Designation:
	For use as an adjunct to surgery, radiation therapy and chemotherapy for 
	the treatment of patients with primary or recurrent malignant glioma.
	Designation 
	3/6/1998	Sponsor and Address
	Marketing Exclusivity 	Elan Drug Delivery, Inc.
	1300 Gould Dr.
	Gainesville GA  30504 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Phenylalanine ammonia-lyase
	Trade Name:
	Phenylase	Orphan Designation:
	Treatment of hyperphenylalaninemia.
	Designation 
	3/8/1995	Sponsor and Address
	Marketing Exclusivity 	Biomarin Pharmaceutical
	105 Digital Drive
	Novato  CA  94949 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Phenylbutyrate
	Trade Name:
	Orphan Designation:
	Treatment of acute promyelocytic leukemia.
	Designation 
	1/19/2000	Sponsor and Address
	Marketing Exclusivity 	Elan Drug Delivery, Inc.
	1300 Gould Dr.
	Gainesville GA  30504 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	phenylephrine
	Trade Name:
	Orphan Designation:
	Treatment of ileal pouch anal anastomosis related fecal incontinence
	Designation 
	2/14/2002	Sponsor and Address
	Marketing Exclusivity 	S.L.A. Pharma
	Unit 3, Hill Farm Industrial Estate
	Leavesden, Watford
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Phosphocysteamine
	Trade Name:
	Orphan Designation:
	Treatment of cystinosis.
	Designation 
	9/12/1988	Sponsor and Address
	Marketing Exclusivity 	Medea Research Laboratories
	Port Jefferson Business Center
	200 Wilson Street, Building D-6
	Port Jefferson NY  11776 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	phosphorothioate oligonucleotide
	Trade Name:
	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis 
	Designation 
	11/9/2007	Sponsor and Address
	Marketing Exclusivity 	Isis Pharmaceuticals, Inc.
	1896 Rutherford Road
	Carlsbad CA  92008 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Picoplatin
	Trade Name:
	Orphan Designation:
	Treatment of small cell lung cancer
	Designation 
	11/2/2005	Sponsor and Address
	Marketing Exclusivity 	Poniard Pharmaceuticals
	300 Elliott Avenue West
	Seattle WA  98119 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pilocarpine	Treatment of symptoms of xerostomia from salivary gland hypofunction 
	caused by radiotherapy for cancer of the head and neck.
	Trade Name:
	Salagen	Orphan Designation:
	Treatment of xerostomia induced by radiation therapy for head and neck 
	cancer.
	Designation 
	9/24/1990	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma, Inc.
	3/22/1994	5775 West Old Shakopee Rd.
	Suite 100
	Bloomington MN  55437-3107
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Pilocarpine HCl	Treatment of dry mouth in patients with Sjogren's syndrome.
	Trade Name:
	Salagen	Orphan Designation:
	Treatment of xerostomia and keratoconjunctivitis sicca in Sjogren's 
	syndrome patients.
	Designation 
	2/28/1992	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma, Inc.
	2/11/1998	5775 West Old Shakopee Rd.
	Suite 100
	Bloomington MN  55437-3107
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Piracetam
	Trade Name:
	Nootropil	Orphan Designation:
	Treatment of myoclonus.
	Designation 
	10/2/1987	Sponsor and Address
	Marketing Exclusivity 	UCB, Inc.
	1950 Lake Park Drive
	Smyrna GA  30080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Piritrexim isethionate
	Trade Name:
	Orphan Designation:
	Treatment of infections caused by Pneumocystis carinii, Toxoplasma 
	gondii, and Mycobacterium avium-intracellulare.
	Designation 
	6/13/1988	Sponsor and Address
	Marketing Exclusivity 	Burroughs Wellcome Company
	3030 Cornwallis Road
	P.O. Box 12700
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Plasmid DNA vector expressing cystic fibrosis 
	transmembrane gene
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	3/29/2005	Sponsor and Address
	Marketing Exclusivity 	Copernicus Therapeutics, Inc.
	11000 Cedar Avenue
	Cleveland OH  44106 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Plevitrexed
	Trade Name:
	Plevitrexed	Orphan Designation:
	Treatment of ovarian cancer
	Designation 
	5/14/2007	Sponsor and Address
	Marketing Exclusivity 	BTG International, Ltd
	10 Fleet Place
	London EC4M 7SB
	    
	UNITED KINGDOM
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Plevitrexed
	Trade Name:
	Plevitrexed	Orphan Designation:
	Treatment of gastric (stomach) cancer
	Designation 
	5/29/2007	Sponsor and Address
	Marketing Exclusivity 	BTG International Ltd
	10 Fleet Place
	London EC4M 7SB
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Plitidepsin
	Trade Name:
	Aplidin 	Orphan Designation:
	Treatment of acute lymphoblastic leukemia
	Designation 
	6/18/2004	Sponsor and Address
	Marketing Exclusivity 	PharmaMar USA, Inc
	University Park at M.I.T.
	The Richards Building 64
	Cambridge MA  02139-4170
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Plitidepsin
	Trade Name:
	Aplidin	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	9/30/2004	Sponsor and Address
	Marketing Exclusivity 	PharmaMar USA, Inc.
	University Park at M.I.T.
	The Rishards Building
	Cambridge MA  02139-4170
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	polifeprosan 20 with carmustine	Expanding the indication to include patients with malignant glioma 
	undergoing primary surgical resection.
	Trade Name:
	Gliadel	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	12/13/1989	Sponsor and Address
	Marketing Exclusivity 	Guilford Pharmaceuticals, Inc.
	2/25/2003	6611 Tributary Street
	Baltimore  MD  21224 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	polifeprosan 20 with carmustine	As an adjunct to surgery to prolong survival in patients with recurrent 
	glioblastoma multiforme for whom surgical resection is indicated
	Trade Name:
	Gliadel	Orphan Designation:
	Treatment of malignant glioma.
	Designation 
	12/13/1989	Sponsor and Address
	Marketing Exclusivity 	Guilford Pharmaceuticals, Inc.
	9/23/1996	6611 Tributary Street
	Baltimore MD  21224 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Poloxamer 188
	Trade Name:
	Orphan Designation:
	Treatment of vasospasm in subarachnoid hemorrhage patients following 
	surgical repair of a ruptured cerebral aneurysm.
	Designation 
	8/5/1997	Sponsor and Address
	Marketing Exclusivity 	CytRx Corporation
	154 Technology Parkway
	Norcross GA  30092 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Poloxamer 188
	Trade Name:
	Flocor	Orphan Designation:
	Treatment of sickle cell crisis.
	Designation 
	6/27/1989	Sponsor and Address
	Marketing Exclusivity 	SynthRx Corporation
	4606 Willow
	Bellaire TX  77401 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Poloxamer 188
	Trade Name:
	Florcor	Orphan Designation:
	Treatment of severe burns requiring hospitalization.
	Designation 
	2/22/1990	Sponsor and Address
	Marketing Exclusivity 	CytRx Corporation
	154 Technology Parkway
	Norcross GA  30092 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Poloxamer 331
	Trade Name:
	Protox	Orphan Designation:
	Initial therapy of toxoplasmosis in patients with AIDS.
	Designation 
	3/21/1991	Sponsor and Address
	Marketing Exclusivity 	CytRx Corporation
	154 Technology Parkway
	Norcross GA  30092 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Poly I: poly C12U
	Trade Name:
	Ampligen	Orphan Designation:
	Treatment of renal cell carcinoma.
	Designation 
	5/20/1991	Sponsor and Address
	Marketing Exclusivity 	Hemispherx Biopharma, Inc.
	One Penn Center
	1617 JFK Boulevard
	Philadelphia PA  19103 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Poly I: poly C12U
	Trade Name:
	Ampligen	Orphan Designation:
	Treatment of invasive metastatic melanoma (stage IIb, III, IV).
	Designation 
	12/9/1993	Sponsor and Address
	Marketing Exclusivity 	Hemispherx Biopharma, Inc.
	One Penn Center
	1617 JFK Boulevard
	Philadelphia PA  19103 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Poly I: poly C12U
	Trade Name:
	Ampligen	Orphan Designation:
	Treatment of chronic fatigue syndrome.
	Designation 
	12/9/1993	Sponsor and Address
	Marketing Exclusivity 	Hemispherx Biopharma, Inc.
	One Penn Center
	1617 JFK Boulevard
	Philadelphia PA  19103 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Poly I: poly C12U
	Trade Name:
	Ampligen	Orphan Designation:
	Treatment of AIDS.
	Designation 
	7/19/1988	Sponsor and Address
	Marketing Exclusivity 	Hemispherx Biopharma, Inc.
	One Penn Center
	1617 JFK Boulevard
	Philadelphia PA  19103 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Polyethylene glycol (PEG)-uricase
	Trade Name:
	Orphan Designation:
	To control the clinical consequences of hyperuricemia in patients with 
	severe gout in whom conventional therapy is contraindicated or has been 
	Designation 	ineffective.
	2/21/2001	Sponsor and Address
	Marketing Exclusivity 	Savient Pharmaceuticals, Inc.
	One Tower Center Boulevard, 14th floor
	East Brunswick NJ  08816 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Polyethylene glycol-modified uricase
	Trade Name:
	Orphan Designation:
	Treatment of hyperuricemia in patients with gout refractory to conventional 
	therapy or in whom conventional therapy is contraindicated
	Designation 
	6/6/2005	Sponsor and Address
	Marketing Exclusivity 	EnzymeRx, LLC
	17 Arcadian Avenue
	Suite 104
	Paramus NJ  07652 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Polyethylene glycol-modified uricase
	Trade Name:
	Zurase	Orphan Designation:
	Prophylaxis of hyperuricemia in cancer patients prone to develop tumor 
	lysis syndrome during chemotherapy.  
	Designation 
	9/14/1999	Sponsor and Address
	Marketing Exclusivity 	EnzymeRx, LLC
	17 Arcadian Avenue
	Suite 104
	Paramus NJ  07652 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Polyethylene glycol-modified uricase
	Trade Name:
	Zurase	Orphan Designation:
	Treatment of tumor lysis syndrome in cancer patients undergoing 
	chemotherapy.    
	Designation 
	12/21/1998	Sponsor and Address
	Marketing Exclusivity 	EnzymeRx, LLC
	17 Arcadian Avenue
	Suite 104
	Paramus NJ  07652 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Poly-ICLC
	Trade Name:
	Hiltonol	Orphan Designation:
	Treatment of primary brain tumors.
	Designation 
	3/17/1997	Sponsor and Address
	Marketing Exclusivity 	Oncovir
	3202 Cleveland Avenue N.W.
	Washington DC  20008 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	polyinosinic-polycytidilic acid
	Trade Name:
	Poly-ICLC	Orphan Designation:
	Treatment of flavivirus infections including those due to West Nile, 
	Japanese encephalitis, dengue, St. Louis encephalitis, yellow fever, Murray
	Designation 	 valley, and Banzai viruses
	3/3/2003	Sponsor and Address
	Marketing Exclusivity 	Oncovir
	3203 Cleveland Ave., NW
	Washington DC  20008-3450
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	polyinosinic-polycytidilic acid
	Trade Name:
	Poly-ICLC	Orphan Designation:
	As an adjuvant to smallpox vaccination
	Designation 
	8/2/2002	Sponsor and Address
	Marketing Exclusivity 	Oncovir
	3203 Cleveland Ave., NW
	Washington DC  20008-3450
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	polyinosinic-polycytidilic acid (Poly-ICLC)
	Trade Name:
	Hiltonol	Orphan Designation:
	Treatment for orthopox virus infections
	Designation 
	11/19/2002	Sponsor and Address
	Marketing Exclusivity 	Oncovir
	3203 Cleveland Ave., NW
	Washington DC  20008-3450
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Polymeric oxygen
	Trade Name:
	Orphan Designation:
	Treatment of sickle cell anemia.
	Designation 
	3/25/1992	Sponsor and Address
	Marketing Exclusivity 	Capmed USA
	P.O. Box 14
	Bryn Mawr PA  19010 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Polyvalent, shed-antigen melanoma vaccine
	Trade Name:
	Orphan Designation:
	Treatment of stage IIb to stage IV melanoma
	Designation 
	6/9/2006	Sponsor and Address
	Marketing Exclusivity 	Polynoma LLC
	11622 El Camino Real #100
	San Diego CA  92130 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Porcine fetal neural dopaminergic cells and/or 
	precursors aseptically prepared and coated with anti-
	MHC-1 Ab for intracerebral implantation
	Trade Name:
	NeuroCell-PD	Orphan Designation:
	Treatment of Hoehn and Yahr stage 4 and 5 Parkinson's disease.
	Designation 
	12/17/1996	Sponsor and Address
	Marketing Exclusivity 	Diacrin/Genzyme LLC
	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Porcine fetal neural dopaminergic cells and/or 
	precursors aseptically prepared for intracerebral 
	Trade Name:
	NeuroCell-PD	Orphan Designation:
	Treatment of Hoehn and Yahr stage 4 and 5 Parkinson's disease.
	Designation 
	12/17/1996	Sponsor and Address
	Marketing Exclusivity 	Diacrin/Genzyme LLC
	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Porcine fetal neural gabaergic cells and/or precursors
	 aseptically prepared and coated with anti-MHC-1 Ab
	 for intracerebral implantation
	Trade Name:
	NeuroCell-HD	Orphan Designation:
	Treatment of Huntington's disease.
	Designation 
	12/10/1996	Sponsor and Address
	Marketing Exclusivity 	Diacrin/Genzyme LLC
	One Kendall Square
	Cambridge MA  02129-1562
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Porcine fetal neural gabaergic cells and/or precursors
	 aseptically prepared for intracerebral implantation 
	for Huntington's disease.
	Trade Name:
	NeuroCell-HD	Orphan Designation:
	Treatment of Huntington's disease.
	Designation 
	12/10/1996	Sponsor and Address
	Marketing Exclusivity 	Diacrin/Genzyme LLC
	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Porcine Sertoli cells aseptically prepared for 
	intracerebral co-implantation with fetal neural tissue
	Trade Name:
	N-Graft	Orphan Designation:
	Treatment of Hoehn and Yahr stage four and five Parkinson's disease.
	Designation 
	6/24/1997	Sponsor and Address
	Marketing Exclusivity 	Titan Pharmaceuticals, Inc.
	Post Office Plaza
	50 Division Street, Suite 503
	Somerville NJ  08876 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	porfimer	For the ablation  of high-grade dysplasia in Barrett's esophagus patients 
	who do not undergo esophagectomy
	Trade Name:
	Photofrin	Orphan Designation:
	For the ablation of High-Grade Dysplasia in Barrett's Esophagus in patients 
	who are not considered to be candidates for esophagectomy
	Designation 
	10/19/2001	Sponsor and Address
	Marketing Exclusivity 	Axcan Scandipharm Inc.
	8/1/2003	22 Inverness Parkway
	Suite 310
	Birmingham AL  35242 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Porfimer sodium
	Trade Name:
	Photofrin	Orphan Designation:
	Treatment of cholangiocarcinoma
	Designation 
	11/18/2004	Sponsor and Address
	Marketing Exclusivity 	Axcan Scandipharm Inc.
	22 Inverness Parkway
	Birmingham AL  35242 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Porfimer sodium	Photodynamic therapy with PHOTOFRIN for the palliation of patients with 
	completely obstructing esophageal cancer, or of patients with partially 
	obstructing esophageal cancer who cannot be satisfactorily treated with 
	Trade Name:	Nd:YAG laser therapy.
	Photofrin	Orphan Designation:
	For the photodynamic therapy of patients with primary or recurrent 
	obstructing (either partially or completely) esophageal carcinoma.
	Designation 
	6/6/1989	Sponsor and Address
	Marketing Exclusivity 	QLT Phototherapeutics, Inc.
	12/27/1995	Lederle Laboratories
	401 North Middletown Road
	Pearl River NY  10965 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Porfimer sodium
	Trade Name:
	Photofrin	Orphan Designation:
	For the photodynamic therapy of patients with transitional cell carcinoma in
	 situ of the urinary bladder.
	Designation 
	11/15/1989	Sponsor and Address
	Marketing Exclusivity 	QLT Phototherapeutics, Inc.
	Lederle Laboratories
	401 North Middletown Road
	Pearl River NY  10965 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Porfiromycin
	Trade Name:
	Promycin	Orphan Designation:
	Treatment of cervical cancer.
	Designation 
	3/13/1997	Sponsor and Address
	Marketing Exclusivity 	Boehringer Ingelheim Pharmaceuticals, Inc.
	900 Ridgebury Road
	PO Box 368
	Ridgefield CT  06877 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Porfiromycin
	Trade Name:
	Promycin	Orphan Designation:
	Treatment of head and neck cancer.
	Designation 
	9/19/1995	Sponsor and Address
	Marketing Exclusivity 	Boehringer Ingelheim Pharmaceuticals, Inc.
	900 Ridgebury Road
	PO Box 368
	Ridgefield CT  06877 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Posaconazole
	Trade Name:
	Posoril	Orphan Designation:
	Treatment of zygomycosis
	Designation 
	7/16/2004	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Road
	Kenilwortoh NJ  07033 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Potassium citrate
	Trade Name:
	Urocit-K	Orphan Designation:
	For avoidance of the complication of calcium stone formation in patients 
	with uric lithiasis.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	University of Texas Health Science Center at Dallas
	8/30/1985	5323 Harry Hines Blvd
	Dallas TX  75235 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Potassium citrate
	Trade Name:
	Urocit-K	Orphan Designation:
	Prevention of calcium renal stones in patients with hypocitraturia.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	University of Texas Health Science Center at Dallas
	8/30/1985	5323 Harry Hines Blvd
	Dallas TX  75235 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Potassium citrate
	Trade Name:
	Urocit-K	Orphan Designation:
	Prevention of uric acid nephrolithiasis.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	University of Texas Health Science Center at Dallas
	8/30/1985	5323 Harry Hines Boulevard
	Dallas TX  75235 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Potassium citrate and citric acid
	Trade Name:
	Orphan Designation:
	For the dissolution and control of uric acid and cysteine calculi in the 
	urinary tract.
	Designation 
	2/14/1986	Sponsor and Address
	Marketing Exclusivity 	Willen Drug Company

	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Potassium Iodide Oral Solution 	For use as a thyroid blocking agent in pediatric patients exposed to 
	radiactive iodine 
	Trade Name:
	ThyroShield	Orphan Designation:
	For use as a thyroid blocking agent in pediatric patients exposed to 
	radiactive iodine
	Designation 
	11/17/2004	Sponsor and Address
	Marketing Exclusivity 	Fleming & Company, Pharmaceuticals
	1/1/9999	1733 Gilsinn Lane
	Fenton MO  63026 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	potassium sodium aluminosilicate
	Trade Name:
	Orphan Designation:
	For treatment of poisoning by or exposure to cesium.
	Designation 
	1/8/2007	Sponsor and Address
	Marketing Exclusivity 	Framework Therapeutics, LLC
	1564 33rd Street, NW
	Washington DC  20007 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	PR1 Vaccine
	Trade Name:
	Orphan Designation:
	Treatment of myelodysplastic syndromes (MDS) requiring therapy.
	Designation 
	9/3/2004	Sponsor and Address
	Marketing Exclusivity 	The Vaccine Company
	P. O. Box 93921
	Carmel CA  93921 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	PR1 Vaccine
	Trade Name:
	Orphan Designation:
	Treatment of acute myelogenous leukemia
	Designation 
	9/3/2004	Sponsor and Address
	Marketing Exclusivity 	The Vaccine Company
	P. O. Box 93921
	Carmel CA  93921 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	PR1 Vaccine
	Trade Name:
	Orphan Designation:
	Treatment of chronic myelogenous leukemia.
	Designation 
	9/3/2004	Sponsor and Address
	Marketing Exclusivity 	The Vaccine Company
	P. O. Box 93921
	Carmel CA  93921 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pr-122 (redox-phenytoin)
	Trade Name:
	Orphan Designation:
	For the emergency rescue treatment of status epilepticus, grand mal type.
	Designation 
	7/5/1990	Sponsor and Address
	Marketing Exclusivity 	Pharmos
	2 Innovation Drive
	Alachua FL  32615 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	PR-225 (redox-acyclovir)
	Trade Name:
	Orphan Designation:
	Treatment of herpes simplex encephalitis in individuals afflicted with AIDS.
	Designation 
	5/29/1990	Sponsor and Address
	Marketing Exclusivity 	Pharmos
	2 Innovation Drive
	Alachua FL  32615 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	PR-239 (redox penicillin G)
	Trade Name:
	Orphan Designation:
	Treatment of AIDS associated neurosyphilis.
	Designation 
	5/23/1990	Sponsor and Address
	Marketing Exclusivity 	Pharmos
	2 Innovation Drive
	Alachua FL  32615 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pr-320 (molecusol-carbamazepine)
	Trade Name:
	Orphan Designation:
	For the emergency rescue treatment of status epilepticus, grand mal type.
	Designation 
	7/20/1990	Sponsor and Address
	Marketing Exclusivity 	Pharmos
	2 Innovation Drive
	Alachua FL  32615 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pralatrexate
	Trade Name:
	Orphan Designation:
	Treatment of T-cell lymphoma
	Designation 
	7/20/2006	Sponsor and Address
	Marketing Exclusivity 	Allos Therapeutics, Inc.
	11080 CirclePoint Road
	Westminster CO  80020 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	pramipexole 
	Trade Name:
	Mirapex	Orphan Designation:
	Treatment of Tourette's syndrome in pediatric patients
	Designation 
	1/31/2008	Sponsor and Address
	Marketing Exclusivity 	Boehringer-Ingelheim Pharmaceuticals, Inc.
	900 Ridgebury Road
	Ridgefield CT  06877 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Pramiracetam Sulfate
	Trade Name:
	Orphan Designation:
	For the management of cognitive dysfunction and enhancement of 
	antidepressant activity associated with electroconvulsive therapy.
	Designation 
	11/4/1991	Sponsor and Address
	Marketing Exclusivity 	Cambridge Neuroscience, Inc.
	1 Kendall Square, Bldg. 700
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Praziquantel
	Trade Name:
	Orphan Designation:
	Treatment of neurocysticercosis.
	Designation 
	4/18/1988	Sponsor and Address
	Marketing Exclusivity 	EM Pharmaceuticals, Inc.

	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Prednimustine
	Trade Name:
	Sterecyt	Orphan Designation:
	Treatment of malignant non-Hodgkin's lymphomas.
	Designation 
	6/17/1985	Sponsor and Address
	Marketing Exclusivity 	Pharmacia Inc.
	P.O. Box 16529
	Columbus OH  43216-6529
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Primaquine phosphate
	Trade Name:
	Orphan Designation:
	For use in combination with clindamycin hydrochloride in the treatment of 
	Pneumocystis carinii pneumonia associated with AIDS.
	Designation 
	7/23/1993	Sponsor and Address
	Marketing Exclusivity 	Sanofi Winthrop, Inc.
	90 Park Avenue
	New York NY  10016 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Procarbazine HCl
	Trade Name:
	Matulane	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	8/8/2006	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	800 South Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Progesterone
	Trade Name:
	Orphan Designation:
	Establishment and maintenance of pregnancy in women undergoing in 
	vitro fertilization or embryo transfer procedures.
	Designation 
	12/22/1994	Sponsor and Address
	Marketing Exclusivity 	Watson Laboratories, Inc.
	311 Bonnie Circle
	Corona CA  91720 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Propamidine isethionate 0.1% ophthalmic solution
	Trade Name:
	Brolene	Orphan Designation:
	Treatment of acanthamoeba keratitis.
	Designation 
	3/10/1988	Sponsor and Address
	Marketing Exclusivity 	Bausch & Lomb
	Pharmaceuticals Division
	8500 Hidden River Parkway
	Tampa FL  33637 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Prostaglandin E1 enol ester  (AS-013)
	Trade Name:
	Circulase	Orphan Designation:
	Treatment of Fontaine Stage IV chronic critical limb ischemia.
	Designation 
	6/12/1998	Sponsor and Address
	Marketing Exclusivity 	LTT Baio-Pharma Co., Ltd
	Research & Development Division
	2-5-1 Atago, Minato-ku, Tokyo
	    
	JAPAN
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Prostaglandin E1 in lipid emulsion
	Trade Name:
	Lipo-PGE1	Orphan Designation:
	Treatment of ischemic ulceration of the lower limbs due to peripheral 
	arterial disease.
	Designation 
	9/10/1996	Sponsor and Address
	Marketing Exclusivity 	Alpha Therapeutic Corporation
	5555 Valley Boulevard
	Los Angeles CA  90032 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Protaxel
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer
	Designation 
	5/21/2003	Sponsor and Address
	Marketing Exclusivity 	Biophysica, Inc.
	2159 Avenida de la Playa
	Suite B
	La  Jolla CA  92037 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Protein C concentrate	Prevention and treatment of venous thrombosis and purpura fulminans
	Trade Name:
	Ceprotin	Orphan Designation:
	For replacement therapy in congenital protein C deficiency for the 
	prevention and treatment of thrombosis, pulmonary emboli, and purpura 
	Designation 	fulminans.
	6/23/1992	Sponsor and Address
	Marketing Exclusivity 	Baxter Healthcare Corporation
	3/30/2007	One Baxter Way
	West Lake Village CA  91362 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Protein C concentrate
	Trade Name:
	Protein C Concentrate (human) Vapor Heated, 	Orphan Designation:
	Immuno
	For use in the prevention and treatment of purpura fulminans in 
	meningococcemia.
	Designation 
	4/22/1993	Sponsor and Address
	Marketing Exclusivity 	Immuno Clinical Research Corp.
	750 Lexington Avenue, 19th Floor
	New York NY  10022 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Protein C concentrate
	Trade Name:
	Protein C Concentrate (human) Vapor Heated, 	Orphan Designation:
	Immuno
	For replacement therapy in patients with congenital or acquired protein C 
	deficiency for the prevention and treatment of warfarin-induced skin 
	Designation 	necrosis during oral anticoagulation.
	6/19/1992	Sponsor and Address
	Marketing Exclusivity 	Immuno Clinical Research Corp.
	750 Lexington Avenue, 19th Floor
	New York NY  10022 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Protirelin
	Trade Name:
	Orphan Designation:
	Prevention of infant respiratory distress syndrome associated with 
	prematurity.
	Designation 
	8/24/1993	Sponsor and Address
	Marketing Exclusivity 	UCB Pharma, Inc.
	1950 Lake Park Drive
	Smyrna GA  30080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Protirelin injection
	Trade Name:
	Orphan Designation:
	Treatment of amyothrophic lateral sclerosis.
	Designation 
	1/10/1985	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	200 Abbott Park Road
	Abbott Park IL   
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Pulmonary surfactant replacement
	Trade Name:
	Orphan Designation:
	Prevention and treatment of infant respiratory distress syndrome.
	Designation 
	12/5/1988	Sponsor and Address
	Marketing Exclusivity 	Scios Nova, Inc.
	2450 Bayshore Parkway
	Mountain View CA  94043 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pulmonary surfactant replacement, porcine	Treatment (rescue) of respiratory distress syndrome in premature infants.
	Trade Name:
	Curosurf	Orphan Designation:
	For the treatment and prevention of respiratory distress syndrome in 
	premature infants.
	Designation 
	8/2/1993	Sponsor and Address
	Marketing Exclusivity 	Dey Laboratories
	1/1/9999	2751 Napa Valley Corporate Drive
	Napa CA  94558 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Purified extract of Pseudomonas aeruginosa
	Trade Name:
	ImmuDyn	Orphan Designation:
	Treatment of immune thrombocytopenia purpura where it is required to 
	increase platelet counts.
	Designation 
	9/22/1997	Sponsor and Address
	Marketing Exclusivity 	Able Laboratories, Inc.
	200 Highland Avenue
	Suite 30
	Needham MA  02494 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Purified type II collagen
	Trade Name:
	Colloral	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis.
	Designation 
	2/9/1995	Sponsor and Address
	Marketing Exclusivity 	AutoImmune, Inc.
	128 Spring Street
	Lexington MA  02421 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pyruvate
	Trade Name:
	Orphan Designation:
	Treatment of interstitial lung disease.
	Designation 
	2/21/2001	Sponsor and Address
	Marketing Exclusivity 	Cellular Sciences, Inc
	84 park Avenue
	P.O. Box 968
	Flemington NJ  08822 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Quinacrine hydrochloride
	Trade Name:
	Orphan Designation:
	For prevention of recurrence of pneumothorax in patients at high risk of 
	recurrence.
	Designation 
	10/17/1984	Sponsor and Address
	Marketing Exclusivity 	Lyphomed, Inc.

	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	quinine Sulfate	Treatment of uncomplicated Plasmodium falciparum malaria
	Trade Name:
	Orphan Designation:
	Treatment of malaria 
	Designation 
	6/3/2004	Sponsor and Address
	Marketing Exclusivity 	AR Holding Company, Inc.
	8/12/2005	1100 Orthodox Street
	Philadelphia PA  19124 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	R-(-)-gossypol 
	Trade Name:
	Orphan Designation:
	Treatment of chronic lymphocytic leukemia.
	Designation 
	10/24/2006	Sponsor and Address
	Marketing Exclusivity 	Ascenta Therapeutics, Inc.
	101 Lindenwood Drive
	Suite 405
	Malvern PA  19355 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rAAV2-CB-hRPE65
	Trade Name:
	Orphan Designation:
	Treatment of type II Leber's Congential Amaurosis
	Designation 
	2/11/2005	Sponsor and Address
	Marketing Exclusivity 	Applied Genetic Technologies Corp.
	11801 Research Drive
	Suite D
	Alachua FL  32615 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rabbit anti-human thymocyte globulin (rATG)
	Trade Name:
	Thymoglobulin	Orphan Designation:
	Induction treatment to prevent rejection and to minimize maintenance 
	immunosupression in pediatric liver transplant recipients
	Designation 
	9/26/2006	Sponsor and Address
	Marketing Exclusivity 	Children's Hospital of Pittsburgh
	University of Pittsburgh
	Pittsburgh PA  15213 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Raloxifene 	Reduction in risk of invasive breast cancer in postmenopausal women with 
	osteoporosis and reduction in risk of invasive breast cancer in 
	postmenopausal women at high risk for invasive breast cancer
	Trade Name:
	Evista	Orphan Designation:
	Reduction of the risk of breast cancer in  postmenopausal women
	Designation 
	7/14/2005	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly and Company
	9/13/2007	Lilly Corporate Center
	Drop Code 1853
	Indianapolis IN  46285 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ranprinase
	Trade Name:
	Onconase	Orphan Designation:
	Treatment for malignant mesothelioma
	Designation 
	1/25/2007	Sponsor and Address
	Marketing Exclusivity 	Alfacell Corporation
	225 Belleville Ave.
	Bloomfield NJ  07003 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rapamycin
	Trade Name:
	Orphan Designation:
	Treatment of tuberous sclerosis complex
	Designation 
	3/20/2007	Sponsor and Address
	Marketing Exclusivity 	OncoImmune, Inc.
	1275 Kinnear Road 
	Columbus OH  43212 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rapamycin (mTOR) inhibitor
	Trade Name:
	Orphan Designation:
	Treatment of bone sarcoma
	Designation 
	8/9/2005	Sponsor and Address
	Marketing Exclusivity 	ARIAD Pharmaceuticals, Incx.
	26 Landsdowne Street
	Cambridge MA  02139-4234
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rasburicase	Initial management of plasma uric acid levels in pediatric patients with 
	leukemia,lymphoma, and solid tumor malignancies who are receiving anti-
	cancer therapy expected to result in tumor lysis and subsequent elevation of
	Trade Name:	 plasma uric acid.
	Elitek	Orphan Designation:
	Treatment of malignancy-associated or chemotherapy-induced 
	hyperuricemia.
	Designation 
	10/11/2000	Sponsor and Address
	Marketing Exclusivity 	Sanofi-Synthelabo Research
	7/12/2002	9 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	raxibacumab
	Trade Name:
	Abthrax	Orphan Designation:
	Treatment of anthrax
	Designation 
	11/12/2003	Sponsor and Address
	Marketing Exclusivity 	Human Genome Sciences, Inc.
	14200 Shady Grove Road
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant adeno-associated virus alpha 1-
	antitrypsin vector
	Trade Name:
	rAAV-AAT	Orphan Designation:
	Treatment of alpha1-antitrypsin deficiency
	Designation 
	1/27/2003	Sponsor and Address
	Marketing Exclusivity 	Applied Genetic Technologies Corp.
	12085 Research Drive
	Suite 110
	Alachua FL  32615 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant anti-CD22 immunotoxin
	Trade Name:
	Orphan Designation:
	Treatment of CD22-positive chronic lymphocytic leukemia
	Designation 
	11/15/2007	Sponsor and Address
	Marketing Exclusivity 	Cambridge Antibody Technology, INc.
	3260 Hillview Avenue
	Palo Alto CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant anti-CD22 immunotoxin
	Trade Name:
	Orphan Designation:
	Treatment of CD22-positive hairy cell leukemia
	Designation 
	11/15/2007	Sponsor and Address
	Marketing Exclusivity 	Cambridge Antibody Technology, Inc.
	3260 Hillview Avenue
	Palo Alto CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant anti-CD40 monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	8/12/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceutical Corporation
	Oncology Business Unit
	One Health Plaza
	East Hanover NJ  07986 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant anti-CD-40 monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	1/25/2006	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceutical Corporation
	Oncology Business Unit
	One Health Plaza
	East Hanover NJ  07936 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant bactericidal/permeability-increasing 
	protein
	Trade Name:
	Neuprex	Orphan Designation:
	Treatment of severe meningococcal disease.
	Designation 
	6/22/1998	Sponsor and Address
	Marketing Exclusivity 	Xoma (US) LLC
	2910 Seventh Street
	Berkeley CA  94710 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant chimeric monoclonal antibody to anthrax
	Trade Name:
	Anthim	Orphan Designation:
	Treatment of exposure to B. anthracis spores
	Designation 
	6/9/2006	Sponsor and Address
	Marketing Exclusivity 	Elusys Therapeutics, Inc.
	25 Riverside Drive
	P.O. Box 102
	Pine Brook NJ  07058 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant coagulation factor VIIa
	Trade Name:
	Novoseven	Orphan Designation:
	Treatment of diffuse alveolar hemorrhage
	Designation 
	4/26/2006	Sponsor and Address
	Marketing Exclusivity 	PharmaOrigin ApS
	Agern Alle 3
	2970 Horsholm
	    
	DENMARK
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant deriative of C3 transferase
	Trade Name:
	Cethrin	Orphan Designation:
	Treatment of acute spinal cord injury
	Designation 
	11/18/2005	Sponsor and Address
	Marketing Exclusivity 	Alseres Pharmaceuticals, Inc.
	85 Main Street
	Hopkinton MA  01748 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant Epstein-Barr virus gp350 glycoprotein 
	vaccine
	Trade Name:
	Orphan Designation:
	Prevention of post-transplantation lymphoproliferative disorders in pediatric 
	recipients of solid-organ transplantation
	Designation 
	8/18/2005	Sponsor and Address
	Marketing Exclusivity 	Henogen S.A.
	Rue des Professeurs Jenner et Brachet, 12
	B-6041-Gosselies
	    
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant fusion protein with a truncated form of 
	the cytotoxic protein Pseudomonas exotoxin
	Trade Name:
	Proxinium	Orphan Designation:
	Treatment of Ep-CAM-positive squamous cell carcinoma of the head and 
	neck
	Designation 
	1/28/2005	Sponsor and Address
	Marketing Exclusivity 	Viventia Biotech, Inc.
	10 Four Seasons Place
	Toronto ON      M9B 6H7    
	 
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant glycine2-human glucagon-like peptide-2
	Trade Name:
	Orphan Designation:
	Treatment of short bowel syndrome.
	Designation 
	6/29/2000	Sponsor and Address
	Marketing Exclusivity 	NPS Allelix Corp.
	6850 Goreway Dr.
	Mississauga
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human acid alpha-glucosidase	For use in patients with Pompe disease (GAA deficiency).  Alglucosidase 
	alfa has been shown to improve ventilator-free survival in patients with 
	infantile onset Pompe disease as compared to an untreated historical 
	Trade Name:	control, whereas use of Alphaglucosidase in patients with other forms of 
	Pompe disease has not been adequately studied to assure safety and 
	Myozyme	Orphan Designation:
	Treatment of glycogen storage disease type II.
	Designation 
	8/19/1997	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	4/28/2006	One Kendall Square
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human alpha 1-antitrypsin 
	Trade Name:
	Orphan Designation:
	Prevention of bronchopulmonary dysplasia
	Designation 
	4/28/2005	Sponsor and Address
	Marketing Exclusivity 	Arriva Pharmaceuticals, Inc.
	1010 Atlantic Avenue
	Alameda CA  94501 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	recombinant human alpha 1-antitrypsin (rAAT)
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	11/20/2001	Sponsor and Address
	Marketing Exclusivity 	Arriva Pharmaceuticals, Inc.
	2020 Challenger Drive
	Alameda CA  94501 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant human alpha-1 antitrypsin
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	3/6/1998	Sponsor and Address
	Marketing Exclusivity 	PPL Therapeutics (Scotland) Limited
	Roslin, Edinburgh
	EH259PP Scotland
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant human alpha-1 antitrypsin (rAAT)
	Trade Name:
	Orphan Designation:
	To delay progression of chronic obstructive pulmonary disease resulting 
	from AAT deficiency-mediated emphysema and bronchiectasis
	Designation 
	8/28/2001	Sponsor and Address
	Marketing Exclusivity 	Arriva Pharmaceuticals, Inc.
	1010 Atlantic Avenue
	Alameda CA  94501 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant Human Alpha-Fetoprotein (rhAFP)
	Trade Name:
	Orphan Designation:
	Treatment of myasthenia gravis
	Designation 
	2/22/2001	Sponsor and Address
	Marketing Exclusivity 	Merrimack Pharmaceuticals, Inc.
	101 Binney Street
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human alpha-mannosidase
	Trade Name:
	Orphan Designation:
	Treatment of alpha-mannosidosis
	Designation 
	2/2/2006	Sponsor and Address
	Marketing Exclusivity 	Zymenex A/S
	Roskildevej 12 C

	DENMARK
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant human anti-GDF-8 (growth and 
	differentiation factor-8) antibody
	Trade Name:
	Orphan Designation:
	Treatment of Duchenne and Becker muscular dystrophies
	Designation 
	2/16/2005	Sponsor and Address
	Marketing Exclusivity 	Wyeth Pharmaceuticals, Inc.
	P. O. Box 8299
	Philadelphia PA  19101-8299
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human antithrombin
	Trade Name:
	ATryn	Orphan Designation:
	Treatment of congenital antithrombin deficiency to prevent the occurrence 
	of serious, potentially life-threatening venous thromboembolisms which 
	Designation 	may develop as a result of surgical or obstetrical procedures
	12/7/2007	Sponsor and Address
	Marketing Exclusivity 	GTC Biotherapeutics, Inc.
	175 Crossing Blvd
	Framingham MA  01702 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human antithrombin III
	Trade Name:
	Orphan Designation:
	Treatment of antithrombin III dependent heparin resistance requiring 
	anticoagulation.
	Designation 
	4/6/2000	Sponsor and Address
	Marketing Exclusivity 	AT III LLC
	c/o Genzyme Corporation
	15 Pleasant St. Connector, P.O. Box 9322
	Framingham MA  01701 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant human arylsulphatase A
	Trade Name:
	Orphan Designation:
	Treatment of metachromatic leukodystrophy (MLD).
	Designation 
	4/11/2008	Sponsor and Address
	Marketing Exclusivity 	Zymenex A/S
	Roskildevej 12C
	3400 Hillerod
	    
	DENMARK
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human C1 inhibitor
	Trade Name:
	Orphan Designation:
	Treatment of capillary leakage syndrome 
	Designation 
	6/9/2006	Sponsor and Address
	Marketing Exclusivity 	Pharming Technologies B.V.
	Archimedesweg 4

	NETHERLANDS
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant human C1 inhibitor
	Trade Name:
	Orphan Designation:
	Prevention and/or treatment of delayed graft function after solid organ 
	transplantation
	Designation 
	6/9/2006	Sponsor and Address
	Marketing Exclusivity 	Pharming Technologies B.V.
	Archimedesweg 4

	NETHERLANDS
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human C1-esterase inhibitor
	Trade Name:
	Orphan Designation:
	Treatment of (acute attacks of) angioedema caused by hereditary or 
	acquired C1-esterase inhibitor deficiency.  
	Designation 
	2/23/1999	Sponsor and Address
	Marketing Exclusivity 	Pharming N.V.
	Cipalstreet 3
	B-2440 Geel
	    
	BELGIUM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human C1-esterase inhibitor
	Trade Name:
	Orphan Designation:
	Prophylactic treatment of angioedema caused by hereditary or acquired 
	C1-esterase inhibitor deficiency.  
	Designation 
	2/23/1999	Sponsor and Address
	Marketing Exclusivity 	Pharming N.V.
	Cipalstreet 3
	B-2440 Geel
	    
	BELGIUM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human CD4 immunoglobulin G
	Trade Name:
	Orphan Designation:
	Treatment of AIDS resulting from infection with HIV-1.
	Designation 
	8/30/1990	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human Clara Cell 10kDa protein
	Trade Name:
	Orphan Designation:
	Prevention of neonatal bronchopulmonary dysplasia in premature neonates
	 with respiratory distress syndrome.
	Designation 
	7/13/1998	Sponsor and Address
	Marketing Exclusivity 	CC10 Sweden AB
	Kornhamnstorg 53
	Box 2077
	    
	SWEDEN
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant human endostatin protein
	Trade Name:
	Orphan Designation:
	Treatment of neuroendocrine tumors
	Designation 
	8/13/2001	Sponsor and Address
	Marketing Exclusivity 	EntreMed, Inc.
	9640 Medical Center Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant human endostatin protein
	Trade Name:
	Orphan Designation:
	Treatment of metastatic melanoma
	Designation 
	2/21/2002	Sponsor and Address
	Marketing Exclusivity 	EntreMed, Inc.
	9640 Medical Center Drive
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human fibrinogen
	Trade Name:
	Orphan Designation:
	Treatment of bleeding in patients deficient in fibrinogen
	Designation 
	10/4/2007	Sponsor and Address
	Marketing Exclusivity 	Pharming Technologies B.V.
	Archimedesweg 4

	NETHERLANDS
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant human fibroblast growth factor-20
	Trade Name:
	Orphan Designation:
	Treatment of radiation induced oral mucositis 
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	CuraGen Corporation
	322 East Main Street
	Branford CT  06405 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human gelsolin
	Trade Name:
	Orphan Designation:
	Treatment of acute and chronic respiratory symptoms of bronchiectasis.
	Designation 
	3/6/1995	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant human gelsolin
	Trade Name:
	Orphan Designation:
	Treatment of the respiratory symptoms of cystic fibrosis.
	Designation 
	1/12/1994	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02124 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human granulocyte colony stimulating 
	factor
	Trade Name:
	Orphan Designation:
	Prevention of implantation failure 
	Designation 
	7/24/2006	Sponsor and Address
	Marketing Exclusivity 	Nora, LLC
	2400 Boston Street
	Baltimore MD  21224 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human highly phosphorylated acid 
	alpha-glucosidase
	Trade Name:
	TBD	Orphan Designation:
	For enzyme replacement therapy in patients with all subtypes of glycogen 
	storage disease type II (GSDII, Pompe Disease)
	Designation 
	9/20/2000	Sponsor and Address
	Marketing Exclusivity 	Novazyme Pharmaceuticals, Inc.
	800 Research Parkway
	Suite 200
	Oklahoma City OK  73104 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human insulin-like growth factor 1
	Trade Name:
	IGF-1	Orphan Designation:
	Treatment of growth hormone receptor deficiency.
	Designation 
	6/7/1995	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	7000 Portage Road
	Kalamazoo MI  49001-0199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human insulin-like growth factor 1
	Trade Name:
	IGF-1	Orphan Designation:
	Treatment of antibody-mediated growth hormone resistance in patients with
	 isolated growth hormone deficiency Ia.
	Designation 
	6/7/1995	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	7000 Portage Road
	Kalamazoo MI  49001-0199
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant human insulin-like growth factor-I
	Trade Name:
	PV802	Orphan Designation:
	Treatment of short-bowel syndrome as a result of resection of the small 
	bowel or as a result of congenital dysfunction of the intestines.
	Designation 
	2/16/2000	Sponsor and Address
	Marketing Exclusivity 	GroPep Pty Ltd.
	Gate 11, Victoria Dr.
	Adelaide SA 5000
	    
	AUSTRALIA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human insulin-like growth factor-I
	Trade Name:
	Orphan Designation:
	Treatment of post-poliomyelitis syndrome.
	Designation 
	10/13/1995	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	41 Moores Road
	P. O. Box 4011
	Frazer PA  19355 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human insulin-like growth factor-
	I/insulin-like growth factor binding protein-3
	Trade Name:
	Orphan Designation:
	Treatment of major burns that require hospitalization. 
	Designation 
	6/15/1999	Sponsor and Address
	Marketing Exclusivity 	Insmed, Inc.
	P.O. Box 2400
	Glen Allen VA  23058-2400
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human interleukin-12
	Trade Name:
	Orphan Designation:
	Treatment of renal cell carcinoma.
	Designation 
	10/20/1997	Sponsor and Address
	Marketing Exclusivity 	Genetics Institute, Inc.
	87 CambridgePark Drive
	Cambridge MA  02140 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant Human Interleukin-21 (rIL-21)
	Trade Name:
	Orphan Designation:
	Treatment of stage II (T4), III or IV malignant melanoma.
	Designation 
	10/4/2005	Sponsor and Address
	Marketing Exclusivity 	Zymo Genetics, Inc
	1201 Eastlake Avenue East
	Seattle WA  98102 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant human keratinocyte growth factor
	Trade Name:
	Orphan Designation:
	Reducing the incidence and severity of radiation-induced xerostomia.
	Designation 
	12/20/1999	Sponsor and Address
	Marketing Exclusivity 	Amgen Inc.
	One Amgen Center Dr.
	Thousand Oaks CA  91320-1799
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human luteinizing hormone	Luveris (lutropin alfa for injection), concomitantly administered with Gonal-f
	 (follitropin alfa for injection), is indicated for stimulation of follicular 
	development in infertile hypogonadotropic hypogonadal women with 
	Trade Name:	profound LH deficiency (LH (less than) 1.2 IU/L).
	Luveris	Orphan Designation:
	For use in association with recombinant human follicle stimulating 
	hormone for the treatment of women with chronic anovulation due to 
	Designation 	hypogonadotropic hypogonadism.
	10/7/1994	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	10/8/2004	One Technology Place
	Rockland  MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human lysosomal acid lipase or 
	cholesteryl ester hydrolase
	Trade Name:
	Cholestrase	Orphan Designation:
	Treatment of lipase deficiencies, including Wolman Disease and 
	cholesteryl ester storage disease
	Designation 
	7/14/2005	Sponsor and Address
	Marketing Exclusivity 	Large Scale Biology Corporation
	3333 Vaca Valley Parkway
	Vacaville CA  95688 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human microplasmin
	Trade Name:
	Orphan Designation:
	Treatment of peripheral arterial occlusion 
	Designation 
	1/23/2006	Sponsor and Address
	Marketing Exclusivity 	ThromboGenics Ltd
	Unit 14, Bridgecourt Office Park
	Dublin    
	 
	IRELAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant human monoclonal antibody to hsp90
	Trade Name:
	Mycograb	Orphan Designation:
	Treatment of invasive candidiasis
	Designation 
	9/16/2002	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corp.
	One Health Plaza
	East Hanover NJ  07936-1080
	 
	UNITED KINGDOM
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant human nerve growth factor
	Trade Name:
	Orphan Designation:
	Treatment of HIV-associated sensory neuropathy.
	Designation 
	4/16/1999	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1 DNA Way
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant human neutrophil inhibitor (hNE)
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	12/9/2003	Sponsor and Address
	Marketing Exclusivity 	Dyax Corporation
	300 Technology Square
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human platelet derived growth factor BB
	Trade Name:
	Orphan Designation:
	Treatment of osteonecrosis of the jaws
	Designation 
	2/1/2007	Sponsor and Address
	Marketing Exclusivity 	Luitpold Pharmaceuticals, Inc.
	P. O. Box 9001 
	One Luitpold Drive
	Shirley NY  11967 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant human porphobilinogen deaminase
	Trade Name:
	Porphozyme	Orphan Designation:
	Treatment of acute intermittent porphyria attacks
	Designation 
	9/9/2002	Sponsor and Address
	Marketing Exclusivity 	Zymenex A/S
	Roskildevej 12C
	3400 Hillerod
	    
	DENMARK
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant human porphobilinogen deaminase, 
	erythropoetic form
	Trade Name:
	Orphan Designation:
	Treatment of acute intermittent porphyria preventing attacks
	Designation 
	7/11/2002	Sponsor and Address
	Marketing Exclusivity 	ZymmenexA/S
	Roskildevej 12C
	3400 Hillerod
	    
	DENMARK
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant human relaxin
	Trade Name:
	Orphan Designation:
	Treatment of progressive systemic sclerosis.
	Designation 
	11/3/1995	Sponsor and Address
	Marketing Exclusivity 	Connetics Corporation
	3400 West Bayshore Road
	Palo Alto CA  94303 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant human rod-derived cone viability factor
	Trade Name:
	Orphan Designation:
	Treatment of retinitis pigmentosa
	Designation 
	1/7/2008	Sponsor and Address
	Marketing Exclusivity 	Fovea Pharmaceuticals
	12 Rue Jean Antoine de Baif
	Paris    
	 
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human thrombopoietin
	Trade Name:
	Orphan Designation:
	For use in accelerating platelet recovery in patients undergoing 
	hematopoietic stem cell transplantation.
	Designation 
	9/29/1997	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1 DNA Way
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant humanized MAb 5c8
	Trade Name:
	Orphan Designation:
	Prevention of rejection of solid organ transplants.
	Designation 
	3/22/1999	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant humanized MAb 5c8
	Trade Name:
	Orphan Designation:
	Prevention of rejection of pancreatic islet cell transplants.
	Designation 
	3/22/1999	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant humanized MAb 5c8
	Trade Name:
	Orphan Designation:
	Prevention and treatment of Factor VIII/Factor IX inhibitors in patients with 
	hemophilia A or B.
	Designation 
	10/14/1998	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant humanized monclonal antibody 5c8
	Trade Name:
	Orphan Designation:
	Treatment of immune thrombocytopenic purpura.
	Designation 
	2/3/1998	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant humanized monoclonal antibody 5c8
	Trade Name:
	Orphan Designation:
	Treatment of systemic lupus erythematosus.
	Designation 
	2/18/1998	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	recombinant inhibitor of human plasma kallikrein
	Trade Name:
	Orphan Designation:
	Treatment of angioedema
	Designation 
	2/4/2003	Sponsor and Address
	Marketing Exclusivity 	Dyax Corp
	300 Technology Square
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant methionyl brain-derived neurotrophic 
	factor
	Trade Name:
	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis.
	Designation 
	11/28/1994	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	One Amgen Center Dr.
	Thousand Oaks CA  91320-1799
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	recombinant ovine interferon tau 
	Trade Name:
	Tauferon	Orphan Designation:
	Treatment of pediatric multiple sclerosis
	Designation 
	1/25/2005	Sponsor and Address
	Marketing Exclusivity 	PEPGEN Corporation
	1301 Harbor Bay Parkway
	Alameda CA  94502 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant Porcine Factor VIII, B-domain Deleted
	Trade Name:
	Orphan Designation:
	Treatment and prevention of episodic bleeding in patients with inhibitor 
	antibodies to human coagulation factor VIII
	Designation 
	3/16/2004	Sponsor and Address
	Marketing Exclusivity 	Ipsen Limited
	190 Bath Road
	Berkshire S11 3XE
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant P-Selectin glycoprotein ligand
	Trade Name:
	Orphan Designation:
	Prevention of delayed graft function in renal transplant patients
	Designation 
	3/29/2006	Sponsor and Address
	Marketing Exclusivity 	Y's Therapeutics, Inc.
	866 Malcolm Road
	Burlingame CA  94010 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant P-selectin glycoprotein ligand-
	immunoglobulin Ig
	Trade Name:
	Orphan Designation:
	Prevention of ischemia reperfusion injury in all solid organ transplants 
	Designation 
	7/26/2007	Sponsor and Address
	Marketing Exclusivity 	Y's Therapeutics, Inc.
	866 Malcolm Road
	Burlingame CA  94010 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant retroviral vector - glucocerebrosidase
	Trade Name:
	Orphan Designation:
	For use as enzyme replacement therapy for patients with types I, II, or III 
	Gaucher disease.
	Designation 
	11/15/1993	Sponsor and Address
	Marketing Exclusivity 	Genetic Therapy, Inc.
	938 Clopper Road
	Gaithersburg MD  20878 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant secretory leucocyte protease inhibitor
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	3/29/1991	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	3200 Walnut Street
	Boulder CO  80301 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant secretory leucocyte protease inhibitor
	Trade Name:
	Orphan Designation:
	Treatment of congenital alpha-1 antitrypsin deficiency.
	Designation 
	3/29/1991	Sponsor and Address
	Marketing Exclusivity 	Amgen Inc.
	3200 Walnut Street
	Boulder CO  80301 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant soluble human CD4
	Trade Name:
	Receptin	Orphan Designation:
	Treatment of acquired immunodeficiency syndrome.
	Designation 
	11/20/1989	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant soluble human CD4 (rCD4)
	Trade Name:
	Orphan Designation:
	Treatment of AIDS in patients infected with HIV virus.
	Designation 
	3/23/1989	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant T-cell receptor ligand
	Trade Name:
	Orphan Designation:
	Treatment of multiple sclerosis patients who are both HLA-DR2 positive and
	 autoreactive to myelin oligodendrocyte glycoprotein residues 35-55
	Designation 
	5/2/2003	Sponsor and Address
	Marketing Exclusivity 	Artielle ImmunoTherapeutics, Inc.
	9020 SW Washington Square Road
	Suite 380
	Tigard, OR  97223-4332
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Recombinant truncated SPINT2 protease inhibitor
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	6/24/2005	Sponsor and Address
	Marketing Exclusivity 	Aerovance, Inc.
	2929 Seventh Street
	Berkeley CA  94710 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant urate oxidase
	Trade Name:
	Orphan Designation:
	Prophylaxis of chemotherapy-induced hyperuricemia.
	Designation 
	10/11/2000	Sponsor and Address
	Marketing Exclusivity 	Sanofi-Synthelabo Research
	9 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Reduced L-glutathione
	Trade Name:
	Cachexon	Orphan Designation:
	Treatment of AIDS-associated cachexia.
	Designation 
	2/14/1994	Sponsor and Address
	Marketing Exclusivity 	Telluride Pharmaceutical Corporation
	146 Flanders Drive
	Hillsborough NJ  08876 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Remacemide
	Trade Name:
	Ecovia	Orphan Designation:
	Treatment of Huntington's disease.
	Designation 
	3/6/2000	Sponsor and Address
	Marketing Exclusivity 	AstraZeneca LP
	725 Chesterbrook Blvd.
	Wayne PA  19087-5677
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Reparixin
	Trade Name:
	Orphan Designation:
	Prevention of delayed graft function in solid organ transplant
	Designation 
	1/27/2003	Sponsor and Address
	Marketing Exclusivity 	Dompe s.p.a.
	Via Campo di Pile
	67100 - L'Aquila
	    
	ITALY
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	repository corticotropin or adrenocorticotropic hormone
	Trade Name:
	H.P. Acthar Gel	Orphan Designation:
	Treatment of infantile spasms
	Designation 
	5/21/2003	Sponsor and Address
	Marketing Exclusivity 	Questcor Pharmaceuticals,  Inc.
	3260 Whipple Road
	Union City CA  94587-1217
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	resiniferatoxin
	Trade Name:
	Orphan Designation:
	Treatment of intractable pain at end-stage disease
	Designation 
	5/13/2003	Sponsor and Address
	Marketing Exclusivity 	NIH/NIDCR
	Bldg 10/Rm 2N236 - DASS/CC
	10 Convent Drive
	Bethesda MD  20892 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Reslizumab
	Trade Name:
	Orphan Designation:
	Treatment of children with eosinophilic esophagitis
	Designation 
	12/19/2007	Sponsor and Address
	Marketing Exclusivity 	Ception Therapeutics, Inc.
	101 Lindenwood Drive
	Suite 400, Valleybrook III
	Malvern PA  19335 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Respiratory Syncytial Virus Immune Globulin 
	(human)
	Trade Name:
	Hypermune RSV	Orphan Designation:
	Treatment of respiratory syncytial virus lower respiratory tract infections in 
	hospitalized infants and young children.
	Designation 
	9/27/1990	Sponsor and Address
	Marketing Exclusivity 	MedImmune, Inc.
	35 West Watkins Mill Road
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Respiratory syncytial virus immune globulin (Human)	For the prevention of serious lower respiratory tract infections caused by 
	RSV in children less than 24 months of age with bronchopulmonary 
	dysplasia or a history of prematurity (less than or equal to 35 weeks 
	Trade Name:	gestation).
	Respigam	Orphan Designation:
	Prophylaxis of respiratory syncytial virus lower respiratory tract infections in 
	infants and young children at high risk of RSV disease.
	Designation 
	9/27/1990	Sponsor and Address
	Marketing Exclusivity 	MedImmune & Massachussetts Public Health Biologics Labs.
	1/18/1996	35 West Watkins Mill Road
	Gaithersburg MD  20878 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	R-etodolac
	Trade Name:
	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	12/9/2002	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	41 Moores Road
	Frazer  PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	retroviral gamma-c cDNA containing vector
	Trade Name:
	Orphan Designation:
	Treatment of X linked severe combined immune deficiency disease
	Designation 
	4/29/2002	Sponsor and Address
	Marketing Exclusivity 	AVAX technologies, Inc.
	9200 Indian Creek Parkway
	Building 9, Suite 200
	Overland Park KS  66210 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Retroviral vector, R-GC and GC gene 1750
	Trade Name:
	Orphan Designation:
	Treatment of Gaucher disease.
	Designation 
	5/6/1997	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	One Mountain Road
	P.O. Box 9322
	Framingham MA  01701-9322
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Reviparin sodium
	Trade Name:
	Clivarine	Orphan Designation:
	Treatment of deep vein thrombosis which may lead to pulmonary embolism
	 in pediatric patients
	Designation 
	6/18/2001	Sponsor and Address
	Marketing Exclusivity 	Abbott 
	Abbott Laboratories, Dept. 389, Bldg. J-45
	200 Abbott Park Rd.
	Abbott Park IL  60064-6135
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Reviparin sodium
	Trade Name:
	Clivarine	Orphan Designation:
	Long-term treatment of acute deep vein trombosis with or without 
	pulmonary embolism in pregnant patients
	Designation 
	6/18/2001	Sponsor and Address
	Marketing Exclusivity 	Abbott
	Abbott Laboratories, Dept. 389, Bldg. J-45
	200 Abbott Park Rd.
	Abbott Park IL  60064-6133
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	RGG0853, E1A lipid complex
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	9/15/1995	Sponsor and Address
	Marketing Exclusivity 	Targeted Genetics Corporation
	1100 Olive Way, Suite 100
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rhIGF-I/rhIGFBP-3
	Trade Name:
	SomatoKine	Orphan Designation:
	Treatment of extreme insulin resistance syndromes (type A, Rabson-
	Mendenhall syndrome, Leprechaunism, Type B syndrome)
	Designation 
	12/9/2003	Sponsor and Address
	Marketing Exclusivity 	Insmed Inc.
	4851 Lake Brooke Drive
	Glen Allen VA  23060 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rh-microplasmin
	Trade Name:
	Orphan Designation:
	Adjunct to surgery in cases of pediatric vitrectomy
	Designation 
	3/16/2004	Sponsor and Address
	Marketing Exclusivity 	ThromboGenics Inc.
	Unit 14
	Walkinstown Avenue
	Dublin  12    
	IRELAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rho (D) immune globulin intravenous (human)	Treatment of adults and children with chronic and acute immune 
	thrombocytopenic purpura.
	Trade Name:
	WinRho SD	Orphan Designation:
	Treatment of immune thrombocytopenic purpura.
	Designation 
	11/9/1993	Sponsor and Address
	Marketing Exclusivity 	Rh Pharmaceuticals, Inc.
	3/24/1995	104 Chancellor Matheson Road
	Winnipeg, Manitoba
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ribavirin
	Trade Name:
	Virazole	Orphan Designation:
	Treatment of hemorrhagic fever with renal syndrome.
	Designation 
	4/12/1991	Sponsor and Address
	Marketing Exclusivity 	Valeant Pharmaceuticals International
	3300 Hyland Avenue
	Costa Mesa CA  92626 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	ribavirin	Treatment of chronic hepatitis C among previously untreated pediatric 
	patients at least three years of age or older.
	Trade Name:
	REBETOL	Orphan Designation:
	Treatment of chronic hepatitis C in pediatric patients
	Designation 
	4/4/2003	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	7/29/2003	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ricin (blocked) conjugated murine mca (anti-b4)
	Trade Name:
	Orphan Designation:
	For the ex-vivo purging of leukemic cells from the bone marrow of non-T 
	cell acute lymphocytic leukemia patients who are in complete remission.
	Designation 
	1/24/1991	Sponsor and Address
	Marketing Exclusivity 	ImmunoGen, Inc.
	148 Sidney Street
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ricin (blocked) conjugated murine MCA (anti-B4)
	Trade Name:
	Orphan Designation:
	Treatment of B-cell leukemia and B-cell lymphoma.
	Designation 
	11/17/1988	Sponsor and Address
	Marketing Exclusivity 	ImmunoGen, Inc.
	148 Sidney Street
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ricin (blocked) conjugated murine MCA (anti-my9)
	Trade Name:
	Orphan Designation:
	Treatment of myeloid leukemia, including AML, and blast crisis of CML.
	Designation 
	8/3/1989	Sponsor and Address
	Marketing Exclusivity 	ImmunoGen, Inc.
	148 Sidney Street
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ricin (blocked) conjugated murine MCA (anti-my9)
	Trade Name:
	Orphan Designation:
	For use in the ex-vivo treatment of autologous bone marrow and 
	subsequent reinfusion in patients with acute myelogenous leukemia.
	Designation 
	2/1/1990	Sponsor and Address
	Marketing Exclusivity 	ImmunoGen, Inc.
	148 Sidney Street
	Cambridge MA  02139 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Ricin (blocked) conjugated murine MCA (n901)
	Trade Name:
	Orphan Designation:
	Treatment of small cell lung cancer
	Designation 
	1/25/1991	Sponsor and Address
	Marketing Exclusivity 	ImmunoGen, Inc.
	148 Sidney Street
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ricin (blocked) conjugated murine monoclonal 
	antibody (CD6)
	Trade Name:
	Orphan Designation:
	Treatment of cutaneous T-cell lymphomas, acute T-cell leukemia-
	lymphoma, and related mature T-cell malignancies.
	Designation 
	9/6/1994	Sponsor and Address
	Marketing Exclusivity 	ImmunoGen, Inc.
	148 Sidney Street
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rifabutin	Prevention of disseminated Mycobacterium avium complex disease in 
	patients with advanced HIV infections.
	Trade Name:
	Mycobutin	Orphan Designation:
	Prevention of disseminated Mycobacterium avium complex disease in 
	patients with advanced HIV infection.
	Designation 
	12/18/1989	Sponsor and Address
	Marketing Exclusivity 	Adria Laboratories, Inc.
	12/23/1992	P.O. Box 16529
	Columbus OH  43216 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rifabutin
	Trade Name:
	Orphan Designation:
	Treatment of disseminated Mycobacterium avium complex disease.
	Designation 
	12/18/1989	Sponsor and Address
	Marketing Exclusivity 	Pfizer, Inc.
	235 East 42nd Street
	New York NY  10017 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rifalazil
	Trade Name:
	Orphan Designation:
	Treatment of pulmonary tuberculosis.
	Designation 
	4/13/1999	Sponsor and Address
	Marketing Exclusivity 	PathoGenesis Corporation
	201 Elliott Avenue West
	Suite 150
	Seattle WA  98119 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Rifampin
	Trade Name:
	Rifadin I.V.	Orphan Designation:
	For antituberculosis treatment where use of the oral form of the drug is not 
	feasible.
	Designation 
	12/9/1985	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel
	5/25/1989	P.O. Box 9627
	Kansas City MO  64134 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rifampin, isoniazid, pyrazinamide	Short-course treatment of tuberculosis.
	Trade Name:
	Rifater	Orphan Designation:
	For the short-course treatment of tuberculosis.
	Designation 
	9/12/1985	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel
	5/31/1994	P.O. Box 9627
	Kansas City MO  64134 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rifapentine
	Trade Name:
	Priftin	Orphan Designation:
	Prophylactic treatment of Mycobacterium avium complex in patients with 
	AIDS and a CD4+ count less than or equal to 75/mm3.
	Designation 
	3/12/1996	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel, Inc.
	P.O. Box 9627
	Mail Station:  H3-M2516
	Kansas City MO  64134-0627
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rifapentine
	Trade Name:
	Priftin	Orphan Designation:
	Treatment of Mycobacterium avium complex in patients with AIDS.
	Designation 
	6/9/1995	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel , Inc.
	P.O. Box 9627
	Mail Station:  H3-M2516
	Kansas City MO  64134-0627
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rifapentine
	Trade Name:
	Priftin	Orphan Designation:
	Treatment of pulmonary tuberculosis.
	Designation 
	6/9/1995	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel
	6/22/1998	P.O. Box 9627
	Mail Station:  H3-M2516
	Kansas City MO  64134-0627
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Rifaximin
	Trade Name:
	Normix	Orphan Designation:
	Treatment of hepatic encephalopathy
	Designation 
	2/10/1998	Sponsor and Address
	Marketing Exclusivity 	Salix Pharmaceuticals, Inc.
	1700 Perimeter Park Drive
	Morrisville NC  27560 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	RII retinamide
	Trade Name:
	Orphan Designation:
	Treatment of myelodysplastic syndromes.
	Designation 
	5/6/1993	Sponsor and Address
	Marketing Exclusivity 	Sparta Pharmaceuticals, Inc.
	111 Rock Road
	Horsham PA  19044-2310
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rilonacept 	Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS)
	Trade Name:
	Arcalyst	Orphan Designation:
	Treatment of CIAS1-Associated Periodic Syndromes
	Designation 
	12/20/2004	Sponsor and Address
	Marketing Exclusivity 	Regeneron Pharmaceuticals, Inc.
	2/27/2008	777 Old Saw Mill River Road
	Tarrytown NY  10591 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Riluzole
	Trade Name:
	Rilutek	Orphan Designation:
	Treatment of Huntington's disease.
	Designation 
	10/15/1996	Sponsor and Address
	Marketing Exclusivity 	Rhone-Poulenc Rorer Pharmaceuticals, Inc.
	500 Arcola Road
	PO Box 5096
	Collegeville PA  19426-0800
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Riluzole	Treatment of patients with amyotrophic lateral sclerosis.  Riluzole extends 
	survival and/or time to tracheostomy.
	Trade Name:
	Rilutek	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis.
	Designation 
	3/16/1993	Sponsor and Address
	Marketing Exclusivity 	Rhone-Poulenc Rorer Pharmaceuticals, Inc.
	12/12/1995	500 Arcola Road, P.O. Box 1200
	Collegeville PA  19426 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	risedronate sodium
	Trade Name:
	Actonel	Orphan Designation:
	Treatment of patients with osteogenesis imperfecta.
	Designation 
	12/18/2006	Sponsor and Address
	Marketing Exclusivity 	Proctor and Gamble Pharmaceuticals
	8700 Mason-Montgomery Road
	Mason OH  08807 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rituximab
	Trade Name:
	Rituxan	Orphan Designation:
	Treatment of patients with anti-neutrophil cytoplasmic antibody-associated 
	vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-
	Designation 	Strauss Syndrome)
	2/14/2006	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1 DNA Way
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rituximab
	Trade Name:
	Rituxan	Orphan Designation:
	Treatment of immune thrombocytopenic purpura
	Designation 
	3/12/2002	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1 DNA Way
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rituximab
	Trade Name:
	Rituxan	Orphan Designation:
	Treatment of non-Hodgkin's B-cell lymphoma.
	Designation 
	6/13/1994	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	11/26/1997	1 DNA Way, MS 242
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rituximab
	Trade Name:
	Rituxan	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	Biogen IDEC, Inc.
	5200 Research Place
	San Diego CA  92122 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	RNA, ((2',3'-dideoxy-2',3'-imino-2',3'-
	seco)[dimethylamino)phosphinylideneoxy](2'a-5') 
	(CTC CAA CAT CAA GGA AGATGG CAT TTC 
	TAG)), P-[4-[[2-[2-(2-
	hydroxyethoxy)ethoxy]ethoxy]carbonyl]-1-
	Trade Name:
	Orphan Designation:
	Treatment of Duchenne Muscular Dystrophy.
	Designation 
	10/23/2007	Sponsor and Address
	Marketing Exclusivity 	AVI BioPharma, Inc.
	One SW Columbia Street
	Portland OR  97258 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rofecoxib
	Trade Name:
	Vioxx	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis
	Designation 
	3/16/2004	Sponsor and Address
	Marketing Exclusivity 	MERCK  & Co., Inc.
	126 East Lincoln Ave.
	Rahway NJ  07065 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rolespimycin 
	Trade Name:
	Orphan Designation:
	Treatment for gastrointestinal stromal tumor
	Designation 
	8/31/2007	Sponsor and Address
	Marketing Exclusivity 	Infinity Pharmaceuticals, Inc.
	780 Memorial Drive
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	romidepsin
	Trade Name:
	Orphan Designation:
	Treatment of non-Hodgkin T-cell lymphomas
	Designation 
	9/30/2004	Sponsor and Address
	Marketing Exclusivity 	Gloucester Pharmaceuticals, Inc.
	One Broadway
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Roquinimex
	Trade Name:
	Linomide	Orphan Designation:
	To prolong time to relapse in leukemia patients who have undergone 
	autologous bone marrow transplantation.
	Designation 
	7/1/1993	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	7000 Portage Road
	Kalamazoo MI  49001-0199
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Rose Bengal Disodium
	Trade Name:
	Orphan Designation:
	Treatment of metastatic melanoma
	Designation 
	12/20/2006	Sponsor and Address
	Marketing Exclusivity 	Provectus Pharmaceuticals, Inc.
	7327 Oak Ridge Highway
	Knoxville TN  37931 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rSP-C lung surfactant
	Trade Name:
	Venticute	Orphan Designation:
	Treatment of adult respiratory distress syndrome.
	Designation 
	4/3/2000	Sponsor and Address
	Marketing Exclusivity 	Byk Gulden Pharmaceuticals
	Byk-Gulden StraBe 2
	78467 Konstanz
	    
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rSP-C surfactant
	Trade Name:
	Venticute	Orphan Designation:
	For use in patients with pneumonia or aspiration of gastric contents leading 
	to intubation, mechanical ventilation, and severe oxygen impairment
	Designation 
	9/18/2006	Sponsor and Address
	Marketing Exclusivity 	Altana Pharma
	220 Park avenue
	Florham Park NJ  07932 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rubitecan
	Trade Name:
	Orphan Designation:
	Treatment of pediatric patients infected with human immunodeficiency 
	virus and acquired immunodeficiency syndrome
	Designation 
	7/17/2002	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	4140 Dublin Blvd.
	Suite 200
	Dublin CA  94568 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rufinamide
	Trade Name:
	Orphan Designation:
	Treatment of Lennox-Gastaut Syndrome.
	Designation 
	10/8/2004	Sponsor and Address
	Marketing Exclusivity 	Eisai Medical Research, Inc.
	55 Challenger Road
	Ridgefield NJ  07660 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	S(-)-3-[3-amino-phthalimido]-glutaramide
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	3/14/2002	Sponsor and Address
	Marketing Exclusivity 	EntreMed Incorporated
	9640 Medical Center Dr.
	Rockville MD  20850 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sacrosidase	Oral replacement therapy of the genetically determined sucrase deficiency,
	 which is part of congenital sucrease-isomaltase deficiency.
	Trade Name:
	Sucraid	Orphan Designation:
	Treatment of congenital sucrase-isomaltase deficiency.
	Designation 
	12/10/1993	Sponsor and Address
	Marketing Exclusivity 	QOL Medical, LLC
	4/9/1998	12419 198th Drive, NE
	Woodinville WA  98072 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	S-adenosylmethionine
	Trade Name:
	Orphan Designation:
	Treatment of AIDS-myelopathy.
	Designation 
	4/30/1998	Sponsor and Address
	Marketing Exclusivity 	Genopia USA, Inc.
	90 Gold Street, 6N
	New York NY  10038 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	salirasib
	Trade Name:
	Orphan Designation:
	Treatment of panreatic cancer.
	Designation 
	12/18/2006	Sponsor and Address
	Marketing Exclusivity 	Concordia Pharmaceuticals, Inc.
	1550 Sawgrass Corporate Parkway
	Sunrise FL  33323 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	sapropterin	Indicated to reduce blood phenylalanine (Phe) levels in patients with 
	hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive
	 Phenylketonuria (PKU).  Kuvan is to be used in conjunction with a Phe-
	Trade Name:	restricted diet.
	Kuvan	Orphan Designation:
	Treatment of hyperphenylalaninemia
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	Biomarin Pharmaceutical Inc.
	12/13/2007	371 Bel Marin Blvd.
	Novato CA  94949 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Sargramostim
	Trade Name:
	Leukine	Orphan Designation:
	Treatment of neutropenia associated with bone marrow transplant, for the 
	treatment of graft failure and delay of engraftment, and for the promotion 
	Designation 	of early engraftment.
	5/3/1990	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	3/5/1991	51 University Street
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sargramostim	Following induction chemotherapy in older adult patients with acute 
	myelogenous leukemia to shorten time to neutrophil recovery and to reduce
	 the incidence of severe and life-threatening infections and infections 
	Trade Name:	resulting in death.
	Leukine	Orphan Designation:
	To reduce neutropenia and leukopenia and decrease the incidence of 
	death due to infection in patients with acute myelogenous leukemia.
	Designation 
	3/6/1995	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	9/15/1995	51 University Street
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	sarsasapogenin
	Trade Name:
	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis (ALS)
	Designation 
	6/18/2004	Sponsor and Address
	Marketing Exclusivity 	Phytopharm plc
	Corpus Christi House
	Godmanchester, Cambridgeshire  PE29 2HY
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Satumomab pendetide	For determining the extent and location of extraphepatic malignant disease
	 in patients with known colorectal and ovarian cancer.
	Trade Name:
	Oncoscint CR/OV	Orphan Designation:
	Detection of ovarian carcinoma.
	Designation 
	9/25/1989	Sponsor and Address
	Marketing Exclusivity 	Cytogen Corporation
	12/29/1992	600 College Road East
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	SB-408075
	Trade Name:
	Orphan Designation:
	For pancreatic cancer
	Designation 
	12/7/2000	Sponsor and Address
	Marketing Exclusivity 	SmithKline Beecham Pharmaceuticals
	1250 S. Collegeville Road
	Collegeville PA  19426-0989
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	SC-1 monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of patients with CD55 (sc-1) positive gastric tumors
	Designation 
	11/12/2003	Sponsor and Address
	Marketing Exclusivity 	Debiovision Inc.
	666 Sherbrooke Street West, Suite 1400
	Montreal, Quebec
	    
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	SCH 58500
	Trade Name:
	Orphan Designation:
	Treatment of primary ovarian cancer.  
	Designation 
	4/12/1999	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	2000 Galloping Hill Rd.
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	SDF-1 (108) Lysine Dlmer
	Trade Name:
	Orphan Designation:
	Treatment of osteogenic sarcoma
	Designation 
	7/7/2005	Sponsor and Address
	Marketing Exclusivity 	Chemokine Therapeutics Corporation
	190 Agronomy Road (UBC)
	Suite 405
	Vancouver, BC V6T 1Z3    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Secalciferol
	Trade Name:
	Osteo-D	Orphan Designation:
	Treatment of familial hypophosphatemic rickets.
	Designation 
	7/26/1993	Sponsor and Address
	Marketing Exclusivity 	Teva Pharmaceuticals USA
	650 Cathill Rd.
	Sellersville PA  18960 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Secretory leukocyte protease inhibitor
	Trade Name:
	Orphan Designation:
	Treatment of bronchopulmonary dysplasia.
	Designation 
	6/30/1992	Sponsor and Address
	Marketing Exclusivity 	Synergen, Inc.
	1885 33rd Street
	Boulder CO  80301 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Selegiline HCl
	Trade Name:
	Eldepryl	Orphan Designation:
	As an adjuvant to levodopa and carbidopa treatment of idiopathic 
	Parkinson's disease (paralysis agitans), postencephalitic Parkinsonism, and 
	Designation 	symptomatic Parkinsonism.
	11/7/1984	Sponsor and Address
	Marketing Exclusivity 	Somerset Pharmaceuticals, Inc.
	6/5/1989	777 South Harbor Island Boulevard
	Tampa FL  33602 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sermorelin acetate
	Trade Name:
	Geref	Orphan Designation:
	Treatment of idiopathic or organic growth hormone deficiency in children 
	with growth failure.
	Designation 
	9/14/1988	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	9/26/1997	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sermorelin acetate
	Trade Name:
	Geref	Orphan Designation:
	Adjunct to gonadotropin therapy in the induction of ovulation in women 
	with anovulatory or oligo-ovulatory infertility who fail to ovulate in response 
	Designation 	to adequate treatment with clomiphene citrate alone and gonadotropin 
	2/13/1990	Sponsor and Address	therapy alone.
	Marketing Exclusivity 	EMD Serono, Inc.
	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sermorelin acetate
	Trade Name:
	Geref	Orphan Designation:
	Treatment of AIDS-associated catabolism/weight loss.
	Designation 
	12/5/1991	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Serratia marcescens extract (polyribosomes)
	Trade Name:
	Imuvert	Orphan Designation:
	Treatment of primary brain malignancies.
	Designation 
	9/7/1988	Sponsor and Address
	Marketing Exclusivity 	Cell Technology, Inc.
	1668 Valtec Lane
	Boulder CO  80306 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	SGN-30 (anti-CD30 antibody)
	Trade Name:
	Orphan Designation:
	Treatment of CD30 positive T-cell lymphomas
	Designation 
	2/18/2004	Sponsor and Address
	Marketing Exclusivity 	Seattle Genetics, Inc.
	21823 30th Drive Southeast
	Bothell WA  98021 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	SGN-30 (anti-CD30 mAb)
	Trade Name:
	Orphan Designation:
	Treatment of Hodgkin's disease
	Designation 
	7/18/2003	Sponsor and Address
	Marketing Exclusivity 	Seattle Genetics, Inc
	21823 30th Drive, Southeast
	Bothell WA  98021 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	SGN-40 (anti-CD40 antibody)
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma.
	Designation 
	8/13/2004	Sponsor and Address
	Marketing Exclusivity 	Seattle Genetics, Inc.
	21823 30th Drive Southeast
	Bothell WA  98021 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Short chain fatty acid enema
	Trade Name:
	Colomed	Orphan Designation:
	Treatment of chronic radiation proctitis.
	Designation 
	8/19/1997	Sponsor and Address
	Marketing Exclusivity 	Richard I. Breuer, M.D.
	1000 Central Street, Suite 615
	Evanston IL  60201 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Short chain fatty acid solution
	Trade Name:
	Colomed	Orphan Designation:
	Treatment of the active phase of ulcerative colitis with involvement 
	restricted to the left side of the colon.
	Designation 
	5/29/1990	Sponsor and Address
	Marketing Exclusivity 	Richard I. Breuer
	1000 Central Street, Suite 615
	Evanston IL  60201 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Silver sulfadiazine and cerium nitrate
	Trade Name:
	Flammacerium	Orphan Designation:
	Prevention of mortality in severely burned patients.
	Designation 
	11/17/1999	Sponsor and Address
	Marketing Exclusivity 	Synthes (USA)
	1690 Russell Road
	PO Box 1766
	Paoli PA  19301 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	siplizumab
	Trade Name:
	Orphan Designation:
	Treatment of T-cell lymphomas
	Designation 
	7/15/2003	Sponsor and Address
	Marketing Exclusivity 	MedImmune, LLC 
	One MedImmune Way
	Gaithersburg   20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sitaxsentan Sodium
	Trade Name:
	Orphan Designation:
	For the treatment of pulmonary arterial hypertensionin the absence of 
	chronic obstructive pulmonary disease or congestive heart failure
	Designation 
	11/2/2004	Sponsor and Address
	Marketing Exclusivity 	Encysive, L.P.
	6700 West Loop South
	Suite 400
	Bellaire TX  77401 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	SK&F 110679
	Trade Name:
	Orphan Designation:
	For the long term treatment of children who have growth failure due to a 
	lack of adequate endogenous growth hormone secretion.
	Designation 
	5/23/1990	Sponsor and Address
	Marketing Exclusivity 	SmithKline Beecham Pharmaceuticals
	One Franklin Plaza
	Philadelphia PA  19101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium aluminosilicate
	Trade Name:
	Orphan Designation:
	Treatment of chronic hepatic encephalopathy
	Designation 
	3/4/2005	Sponsor and Address
	Marketing Exclusivity 	Framework Therapeutics, LLc
	1564 33rd Street, NW
	Washington DC  20007 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Sodium ascorbate and menadione sodium bisulfite
	Trade Name:
	Apatone	Orphan Designation:
	Treatment of metastatic or locally advanced inoperable transitional cell 
	carcinoma of the urothelium (stage III and IV bladder cancer)
	Designation 
	7/31/2007	Sponsor and Address
	Marketing Exclusivity 	IC-MedTech Corporation
	9902 Indian Creek Lane
	El Cajon CA  92021 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium dichloroacetate
	Trade Name:
	Orphan Designation:
	Treatment of homozygous familial hypercholesterolemia.
	Designation 
	6/11/1990	Sponsor and Address
	Marketing Exclusivity 	Stacpoole, Peter W. M.D., Ph.D.
	University of Florida
	P.O. Box 100277
	Gainesville FL  32610 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium dichloroacetate
	Trade Name:
	Orphan Designation:
	Treatment of congenital lactic acidosis.
	Designation 
	6/11/1990	Sponsor and Address
	Marketing Exclusivity 	Stacpoole, Peter W. M.D., Ph.D.
	University of Florida
	P.O. Box 100277
	Gainesville FL  32610 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium dichloroacetate
	Trade Name:
	Orphan Designation:
	Treatment of congenital lactic acidosis.
	Designation 
	12/31/1997	Sponsor and Address
	Marketing Exclusivity 	Questcor Pharmaceuticals, Inc.
	3260 Whipple Rd.
	Union City CA  94587-1217
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium dichloroacetate
	Trade Name:
	Orphan Designation:
	Treatment of lactic acidosis in patients with severe malaria.
	Designation 
	11/10/1994	Sponsor and Address
	Marketing Exclusivity 	Stacpoole, Peter W. M.D., Ph.D.
	University Of Florida
	P.O. Box 100277
	Gainesville FL  32610 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	sodium dichloroacetate
	Trade Name:
	Orphan Designation:
	Use as an antidote in the management  of systemic monochloroacetic acid 
	 poisoning
	Designation 
	7/3/2003	Sponsor and Address
	Marketing Exclusivity 	EBD Group
	2032 Corte del Nogal
	Suite 120
	Carlsbad CA  92011 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium dichloroacetate
	Trade Name:
	Ceresine	Orphan Designation:
	Treatment of severe head injury.
	Designation 
	6/14/1999	Sponsor and Address
	Marketing Exclusivity 	Questcor Pharmaceuticals, Inc.
	3260 Whipple Rd.
	Union City CA  94587-0700
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium Monomercaptoundecahydro-closo-
	dodecaborate
	Trade Name:
	Borocell	Orphan Designation:
	For use in boron neutron capture therapy (BNCT) in the treatment of 
	glioblastoma multiforme.
	Designation 
	4/15/1992	Sponsor and Address
	Marketing Exclusivity 	Neutron Technology  Corp.& Neutron R&D Partner
	877 Main Street, Suite 402
	Boise ID  83702 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium monomercaptoundecahydro-closo-
	dodecaborate
	Trade Name:
	Orphan Designation:
	For use in conjunction with a thermal or epithermal neutron beam in boron 
	nuclear capture therapy of glioblastoma multiforme.
	Designation 
	12/18/1984	Sponsor and Address
	Marketing Exclusivity 	Theragenics Corporation

	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium nitrite 
	Trade Name:
	Orphan Designation:
	Treatment of vaso-occlusive crisis associated with sickle cell disease
	Designation 
	4/2/2007	Sponsor and Address
	Marketing Exclusivity 	Hope Pharmaceuticals, Inc
	8260 E. Gelding Drive #104
	Scottsdale AZ  85260 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Sodium nitrite
	Trade Name:
	Orphan Designation:
	Treatment of cyanide poisoning
	Designation 
	4/18/2007	Sponsor and Address
	Marketing Exclusivity 	Hope Pharmaceuticals
	8260 East Gelding Drive
	Scottsdale AZ  85260 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium nitrite
	Trade Name:
	Orphan Designation:
	Prevention of vasospasm associated with subarachnoid hemorrhage
	Designation 
	1/17/2007	Sponsor and Address
	Marketing Exclusivity 	Hope Pharmaceuticals
	8260 E. Gelding Drive
	Scottsdale AZ  85260 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium nitrite and sodium thiosulfate
	Trade Name:
	Cyanide Antidote Kit	Orphan Designation:
	Treatment of known or suspected cyanide poisoning
	Designation 
	4/9/2008	Sponsor and Address
	Marketing Exclusivity 	Hope Pharmaceuticals
	8260 E. Gelding Drive 
	Scottsdale AZ  85260 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium nitrite/sodium thiosulfate
	Trade Name:
	Cyanide Antidote Package	Orphan Designation:
	Treatment of cyanide poisoning
	Designation 
	3/23/2007	Sponsor and Address
	Marketing Exclusivity 	Keystone Pharmaceuticals, Inc.
	26072 Merit Circle
	Laguna Hills CA  92653 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium phenylacetate/sodium benzoate 10%/10% 
	Injection
	Trade Name:
	Ammonul	Orphan Designation:
	Treatment of grade III and VI hepatic encephalopathy
	Designation 
	6/3/2005	Sponsor and Address
	Marketing Exclusivity 	Ucyclyd Pharma, Inc.
	8125 North Hayden Road
	Scottsdaale AZ  85258 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Sodium phenylbutyrate
	Trade Name:
	Orphan Designation:
	Treatment of spinal muscular atrophy
	Designation 
	3/20/2007	Sponsor and Address
	Marketing Exclusivity 	Tikvah Therapeutics, Inc.
	75 5th Street, NW.
	Atlanta GA  30308 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium phenylbutyrate
	Trade Name:
	Buphenyl	Orphan Designation:
	Treatment of spinal muscular atrophy
	Designation 
	1/25/2007	Sponsor and Address
	Marketing Exclusivity 	Ucyclyd Pharma, Inc.
	8125 N. Hayden Road
	Scottsdale AZ  85258 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium phenylbutyrate
	Trade Name:
	Orphan Designation:
	For use as an adjuct to surgery, radiation therapy and chemotherapy for the 
	treatment of patients with primary or recurrent malignant glioma.  
	Designation 
	4/24/1998	Sponsor and Address
	Marketing Exclusivity 	Elan Drug Delivery, Inc.
	1300 Gould Dr.
	Gainesville GA  30504 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	sodium phenylbutyrate	Adjunctive therapy in the chronic managment of patients with urea cycle 
	disorders involving deficiencies of carbamylphosphate synthetase, ornithine
	 transcarbamylase, or argininosuccinic acid synthetase.
	Trade Name:
	Buphenyl	Orphan Designation:
	Treatment of urea cycle disorders: carbamylphosphate synthetase 
	deficiency, ornithine transcarbamylase deficiency, and arginiosuccinic acid 
	Designation 	synthetase deficiency.
	11/22/1993	Sponsor and Address
	Marketing Exclusivity 	Medicis Pharmaceutical Corp.
	4/30/1996	8125 N. Hayden Road
	Scottsdale AZ  85258 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	sodium phenylbutyrate
	Trade Name:
	Orphan Designation:
	Treatment for sickling disorders, which include S-S hemoglobinopathy, S-C 
	hemoglobinopathy, and S-thalassemia hemoglobinopathy.
	Designation 
	7/2/1992	Sponsor and Address
	Marketing Exclusivity 	Medicis Pharmaceutical Corp.
	8125 N. Hayden Road
	Scottsdale AZ  85258 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Sodium pyruvate
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis
	Designation 
	3/31/2003	Sponsor and Address
	Marketing Exclusivity 	Cellular Sciences, Inc.
	84 Park Avenue
	P. O. Box 968
	Flemington NJ  08822 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium stibogluconate
	Trade Name:
	Orphan Designation:
	Treatment of cutaneous leishmaniasis 
	Designation 
	6/16/2006	Sponsor and Address
	Marketing Exclusivity 	VioQuest Pharmaceuticals, Inc.
	180 Mt. Airy Road
	Suite 203
	Basking Ridge NJ  07920 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium thiosulfate
	Trade Name:
	Orphan Designation:
	Prevention of platinum-induced ototoxicity in pediatric patients
	Designation 
	3/17/2004	Sponsor and Address
	Marketing Exclusivity 	Adherex Technologies, Inc.
	4620 Creekstone Drive
	Suite 200
	Durham NC  27703 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium thiosulfate and sodium nitrite
	Trade Name:
	Orphan Designation:
	Treatment of cyanide poisoning
	Designation 
	12/18/2006	Sponsor and Address
	Marketing Exclusivity 	Akorn, Inc.
	2500 Millbrook Drive
	Buffalo Grove IL  60089 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sodium thiosulfate, sodium nitrite, amyl nitrite
	Trade Name:
	Cyanide Antidote Package	Orphan Designation:
	Treatment of cyanide poisoning
	Designation 
	6/16/2006	Sponsor and Address
	Marketing Exclusivity 	Keystone Pharmaceuticals, Inc.
	26072 Merit Circle
	Laguna Hills CA  92653 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Solasonine and solamargine
	Trade Name:
	Coramsine	Orphan Designation:
	Treatment of renal cell carcinoma 
	Designation 
	11/2/2005	Sponsor and Address
	Marketing Exclusivity 	Solbec Pharmaceuticals Limited
	P. O. Box 2142
	WA 6018
	    
	AUSTRALIA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Solasonine and solamargine
	Trade Name:
	Coramsine	Orphan Designation:
	Treaatment of high risk stage II, stage III and stage IV melanoma
	Designation 
	2/6/2006	Sponsor and Address
	Marketing Exclusivity 	Solbec Pharmaceuticals Limited
	P. O. Box 2142
	Osbourne Park, Western Australia  6017
	    
	AUSTRALIA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Soluble complement receptor type 1
	Trade Name:
	Orphan Designation:
	Prevention of post-cardiopulmonary bypass syndrome in children 
	undergoing cardiopulmonary bypass.
	Designation 
	3/6/2000	Sponsor and Address
	Marketing Exclusivity 	Avant Immunotherapeutics, Inc.
	119 Fourth Ave.
	Needham MA  02494-2725
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Soluble recombinant human complement receptor 
	type 1
	Trade Name:
	Orphan Designation:
	Prevention or reduction of adult respiratory distress syndrome.
	Designation 
	11/21/1994	Sponsor and Address
	Marketing Exclusivity 	T Cell Sciences, Inc.
	119 Fourth Avenue
	Needham Heights MA  02194 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Solvent/detergent treated non-blood group specific 
	human coagulation active plasma
	Trade Name:
	UNIPLAS	Orphan Designation:
	Treatment of thrombotic thrombocytopenic purpura 
	Designation 
	12/12/2005	Sponsor and Address
	Marketing Exclusivity 	Octapharma USA, Inc.
	121 River Street
	12th Floor
	Hoboken NJ  07030 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Somatostatin
	Trade Name:
	Zecnil	Orphan Designation:
	Adjunct to the non-operative management of secreting cutaneous fistulas of
	 the stomach, duodenum, small intestine (jejunum and ileum), or pancreas.
	Designation 
	6/20/1988	Sponsor and Address
	Marketing Exclusivity 	Ferring Laboratories, Inc.
	400 Rella Boulevard, Suite 201
	Suffern NY  10901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatostatin
	Trade Name:
	Orphan Designation:
	Treatment of bleeding esophageal varices.
	Designation 
	12/22/1994	Sponsor and Address
	Marketing Exclusivity 	UCB, Inc.
	1950 Lake Park Drive
	Smyrna GA  30080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatrem for injection
	Trade Name:
	Protropin	Orphan Designation:
	Treatment of short stature associated with Turner's syndrome.
	Designation 
	12/9/1985	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatrem for injection
	Trade Name:
	Protropin	Orphan Designation:
	For long-term treatment of children who have growth failure due to a lack of
	 adequate endogenous growth hormone secretion.
	Designation 
	12/9/1985	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	10/17/1985	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin  
	Trade Name:
	Humatrope	Orphan Designation:
	Treatment of short stature in pediatric patients with short stature homeobox-
	containing gene (SHOX) deficiency
	Designation 
	12/15/2005	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly and Company
	Lilly Corporate Center
	Indianapolis IN  46285 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Somatropin	Treatment of short stature in patients with Noonan syndrome
	Trade Name:
	Norditropin	Orphan Designation:
	Treatment of short stature in patients with Noonan syndrome
	Designation 
	8/9/2006	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk Inc.
	5/31/2007	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin
	Trade Name:
	Norditropin	Orphan Designation:
	Treatment of short stature associated with Turner's syndrome.
	Designation 
	11/5/1987	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk Pharmaceuticals
	100 Overlook Center
	Suite 200
	Princeton NJ  08540 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin	Treatment of short stature associated with Turner syndrome in patients 
	whose epiphyses are not closed.
	Trade Name:
	Humatrope	Orphan Designation:
	Treatment of short stature associated with Turner syndrome.
	Designation 
	5/8/1990	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly and Company
	12/30/1996	Lilly Corporate Center
	Indianapolis IN  46285 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin
	Trade Name:
	Norditropin	Orphan Designation:
	Adjunct for the induction of ovulation in women with infertility due to 
	hypogonadotropic hypogonadism or bilateral tubal occlusion or 
	Designation 	unexplained infertility, who are undergoing in vivo or in vitro fertilization 
	9/1/1987	Sponsor and Address	procedures.
	Marketing Exclusivity 	Novo Nordisk Pharmaceuticals
	100 Overlook Center
	Suite 200
	Princeton NJ  08540 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin
	Trade Name:
	Biotropin	Orphan Designation:
	Treatment of cachexia associated with AIDS.
	Designation 
	2/12/1993	Sponsor and Address
	Marketing Exclusivity 	Bio-Technology General Corp.
	70 Wood Avenue, South
	Iselin NJ  08830 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Somatropin
	Trade Name:
	Genotropin	Orphan Designation:
	Treatment of adults with growth hormone deficiency.
	Designation 
	9/6/1994	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	10/31/1997	7000 Portage Road
	Kalamazoo MI  49001-0199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin
	Trade Name:
	Serostim	Orphan Designation:
	Treatment of patients with HIV-associated adipose redistribution syndrome
	Designation 
	3/16/2004	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin
	Trade Name:
	Nutropin	Orphan Designation:
	For use in the long-term treatment of children who have growth failure due 
	to a lack of adequate endogenous growth hormone secretion.
	Designation 
	3/6/1987	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	10/17/1985	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin  (rDNA)
	Trade Name:
	Saizen	Orphan Designation:
	For the enhancement of nitrogen retention in hospitalized patients suffering
	 from severe burns.
	Designation 
	5/3/1989	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin (rDNA origin)	Long term treatment of children with growth failure due to inadequate 
	secretion of endogenous growth hormone.  
	Trade Name:
	Saizen	Orphan Designation:
	Treatment of idiopathic or organic growth hormone deficiency in children 
	with growth failure.
	Designation 
	3/6/1987	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	1/1/9999	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Somatropin (rDNA origin)	Long-term treatment of growth failure due to a lack of adequate 
	endogenous growth hormone secetion for once- or twice-a-month 
	administration.
	Trade Name:
	Nutropin Depot	Orphan Designation:
	Long-term treatment of children who have growth failure due to a lack of 
	adequate endogenous growth hormone secretion.  
	Designation 
	10/28/1999	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1/1/9999	1 DNA Way
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin (rDNA origin) injection	Long-term treatment of children who have growth failure due to inadequate
	 secretion of endogenous growth hormone.
	Trade Name:
	Norditropin	Orphan Designation:
	Treatment of growth failure in children due to inadequate growth hormone 
	secretion.
	Designation 
	7/10/1987	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk Pharmaceuticals
	1/1/9999	100 Overlook Center
	Suite 200
	Princeton NJ  08540 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin (r-DNA)	Treatment of short bowel syndrome in patients receiving specialized 
	nutritional support
	Trade Name:
	Zorbtive	Orphan Designation:
	For use alone or in combination with glutamine in the treatment of short 
	bowel syndrome.
	Designation 
	3/6/1995	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	12/1/2003	One Technology Place
	Roackland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin (r-DNA) for injection
	Trade Name:
	Serostim	Orphan Designation:
	Treatment of children with AIDS-associated failure-to-thrive including AIDS-
	associated wasting.
	Designation 
	3/26/1996	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin [rDNA]	Long-term treatment of pediatric patients who have growth failure due to 
	Prader-Willi syndrome (PWS).
	Trade Name:
	Genotropin	Orphan Designation:
	Treatment of short stature in patients with Prader-Willi syndrome.
	Designation 
	7/6/1999	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	6/20/2000	7000 Portage Rd.
	0633-298-113
	Kalamazoo MI  49001-0199
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	somatropin [rDNA]	For long-term treatment of growth failure in children born small for 
	gestational age who fail to manifest catch-up growth by two years of age.
	Trade Name:
	Genotropin	Orphan Designation:
	Treatment of growth failure in children who were born small for gestational 
	age.
	Designation 
	12/27/2000	Sponsor and Address
	Marketing Exclusivity 	Pharmacia and Upjohn Company
	7/25/2001	7000 Portage Road
	Kalamazoo MI  49001 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin for injection
	Trade Name:
	Humatrope	Orphan Designation:
	For the long-term treatment of children who have growth failure due to 
	inadequate secretion of normal endogenous growth hormone.
	Designation 
	6/12/1986	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly and Company
	3/8/1987	Lilly Corporate Center
	Indianapolis IN  46285 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin for injection
	Trade Name:
	Nutropin	Orphan Designation:
	As replacement therapy for growth hormone deficiency in adults after 
	epiphyseal closure.
	Designation 
	11/18/1996	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	12/15/1997	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin for injection	Treatment of children with growth failure associated with chronic renal 
	insufficency.
	Trade Name:
	Nutropin	Orphan Designation:
	Treatment of growth retardation associated with chronic renal failure.
	Designation 
	8/4/1989	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	11/17/1993	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin for injection	Treatment of AIDS wasting or cachexia.
	Trade Name:
	Serostim	Orphan Designation:
	Treatment of AIDS-associated catabolism/weight loss.
	Designation 
	11/15/1991	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	8/23/1996	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Somatropin for injection	Treatment of growth failure associated with Turner syndrome.
	Trade Name:
	Nutropin	Orphan Designation:
	Treatment of short stature associated with Turner's syndrome.
	Designation 
	3/23/1989	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	12/30/1996	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sorafenib	Treatment of unresectable hepatocellular carcinoma
	Trade Name:
	Nexavar	Orphan Designation:
	Treatment of hepatocellular carcinoma
	Designation 
	4/20/2006	Sponsor and Address
	Marketing Exclusivity 	Bayer Pharmaceuticals Corporation
	3/24/2008	400 Morgan Lane
	West Haven CT  06516 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sorafenib
	Trade Name:
	Nexavar	Orphan Designation:
	Treatment of stage IIB through stage IV melanoma
	Designation 
	9/29/2006	Sponsor and Address
	Marketing Exclusivity 	Bayer Pharmaceuticals Corp.
	400 Morgan Lane
	New Haven CT  06516 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sorafenib	Treatment of patients with advanced renal cell carcinoma
	Trade Name:
	Nexavar	Orphan Designation:
	Treatment of renal cell carcinoma.
	Designation 
	10/8/2004	Sponsor and Address
	Marketing Exclusivity 	Bayer Pharmaceutical Corporation
	12/20/2005	400 Morgan Lane
	West Haven CT  06516 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sorivudine
	Trade Name:
	BRAVAVIR	Orphan Designation:
	Treatment of herpes zoster (shingles) in immunocompromised patients.
	Designation 
	11/9/1995	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb
	5 Research Parkway
	P.O. Box 5100
	Wallingford CT  06492 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Sotalol HCl
	Trade Name:
	Betapace	Orphan Designation:
	Prevention of life threatening ventricular tachyarrhythmias.
	Designation 
	9/23/1988	Sponsor and Address
	Marketing Exclusivity 	Berlex Laboratories, Inc.
	300 Fairfield Road
	Wayne NJ  07470 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sotalol HCl
	Trade Name:
	Betapace	Orphan Designation:
	Treatment of life-threatening ventricular tachyarrhythmias.
	Designation 
	9/23/1988	Sponsor and Address
	Marketing Exclusivity 	Berlex Laboratories, Inc.
	10/30/1992	300 Fairfield Road
	Wayne NJ  07470 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	spherical carbon adsorbent
	Trade Name:
	Orphan Designation:
	Treatment of chronic pouchitis
	Designation 
	12/19/2007	Sponsor and Address
	Marketing Exclusivity 	Ocera Therapeutics, Inc.
	12651 High Bluff Drive
	San Diego CA  92130 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Spiramycin
	Trade Name:
	Rovamycine	Orphan Designation:
	For symptomatic relief and parasitic cure of chronic cryptosporidiosis in 
	patients with immunodeficiency.
	Designation 
	10/17/1984	Sponsor and Address
	Marketing Exclusivity 	Rhone-Poulenc Rorer Pharmaceuticals
	500 Arcola Road
	Collegeville PA  19426 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	squalamine lactate	Treatment of ovarian cancer
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer refractory or resistant to standard 
	chemotherapy
	Designation 
	5/11/2001	Sponsor and Address
	Marketing Exclusivity 	Genaera Corporation
	5110 Campus Drive
	Plymouth Meeting PA  19462 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	SS1(dsFv)-PE38
	Trade Name:
	Orphan Designation:
	Treatment of epithelial ovarian cancer
	Designation 
	2/11/2002	Sponsor and Address
	Marketing Exclusivity 	National Institutes of Health
	Cancer Therapy Evaluation Program/DCTD/NCI
	Suite 7111
	Rockville MD  20852 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	SS1(dsFv)-PE38
	Trade Name:
	Orphan Designation:
	Treatment of malignant mesothelioma
	Designation 
	2/11/2002	Sponsor and Address
	Marketing Exclusivity 	National Institutes of Health
	Cancer Therapy Evaluation Program
	NCI/DCTD
	Rockville MD  20852 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ST1-RTA immunotoxin (SR 44163)
	Trade Name:
	Orphan Designation:
	Treatment of patients with B-chronic lymphocytic leukemia.
	Designation 
	8/12/1987	Sponsor and Address
	Marketing Exclusivity 	Sanofi Winthrop, Inc.
	9 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ST1-RTA immunotoxin (SR 44163)
	Trade Name:
	Orphan Designation:
	Prevention of acute graft versus host disease in allogenic bone marrow 
	transplantation.
	Designation 
	8/12/1987	Sponsor and Address
	Marketing Exclusivity 	Sanofi Winthrop, Inc.
	9 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Staphylococcus aureus Immune Globulin (Human)
	Trade Name:
	Altastaph	Orphan Designation:
	Prophylaxis against Staphylococcus aureus infections in low birth weight 
	neonates
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	Biotest Pharmaceuticals Corporation
	5800 Park of Commerce Blvd, NW
	Boca Raton FL  33487 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Stem and progenitor cells derived from ex vivo 
	expanded allogeneic umbilical cord blood
	Trade Name:
	StemEx	Orphan Designation:
	For use as hematopoietic support in patients with relasped or refractory 
	hematologic malignancies who are receiving high-dose therapy
	Designation 
	3/4/2005	Sponsor and Address
	Marketing Exclusivity 	Gamida Cell Ltd
	5, Nahum Hafzadi St.
	Jerusalem 95484
	    
	ISRAEL
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sterile talc
	Trade Name:
	Steritalc	Orphan Designation:
	Treatment of malignant pleural effusion.
	Designation 
	12/8/1997	Sponsor and Address
	Marketing Exclusivity 	Novatech SA
	Avenue du Vent des Dames - Z.l. les Paluds
	13685 Aubagne
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sterile talc
	Trade Name:
	Steritalc	Orphan Designation:
	Treatment of pneumothorax.
	Designation 
	12/8/1997	Sponsor and Address
	Marketing Exclusivity 	Novatech SA
	Avenue du Vent des Dames - Z.l. les Paluds
	13685 Aubagne
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sterile talc powder	Prevention of recurrence of malignant pleural effusions in symptomatic 
	patients.
	Trade Name:
	Sclerosol Intrapleural Aerosol	Orphan Designation:
	Treatment of malignant pleural effusion.
	Designation 
	9/18/1995	Sponsor and Address
	Marketing Exclusivity 	Bryan Corporation
	12/24/1997	4 Plympton Street
	Woburn MA  01801 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	SU101
	Trade Name:
	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	3/12/1996	Sponsor and Address
	Marketing Exclusivity 	Sugen, Inc.
	230 East Grand Ave.
	South San Francisco CA  94080-4811
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	SU101
	Trade Name:
	Orphan Designation:
	Treatment of malignant glioma.
	Designation 
	5/25/1995	Sponsor and Address
	Marketing Exclusivity 	Sugen, Inc.
	230 East Grand Ave.
	South San Francisco CA  94080-4811
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Succimer
	Trade Name:
	Chemet	Orphan Designation:
	Treatment of mercury intoxication.
	Designation 
	3/22/1991	Sponsor and Address
	Marketing Exclusivity 	Sanofi Winthrop, Inc.
	90 Park Avenue
	New York NY  10016-1389
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Succimer
	Trade Name:
	Chemet	Orphan Designation:
	Prevention of cystine kidney stone formation in patients with homozygous 
	cystinuria who are prone to stone development.
	Designation 
	11/5/1990	Sponsor and Address
	Marketing Exclusivity 	Sanofi Winthrop, Inc.
	90 Park Avenue
	New York NY  10016-1389
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Succimer
	Trade Name:
	Chemet capsules	Orphan Designation:
	Treatment of lead poisoning in children.
	Designation 
	5/9/1984	Sponsor and Address
	Marketing Exclusivity 	Bock Pharmacal Company
	12/22/1988	P.O. Box 419056
	Saint Louis MO  63141-9056
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sucralfate
	Trade Name:
	Orphan Designation:
	Treatment of oral mucositis and stomatitis following radiation therapy for 
	head and neck cancer.
	Designation 
	7/15/1993	Sponsor and Address
	Marketing Exclusivity 	Fuisz Technologies, Ltd.
	14555 Avion at Lakeside
	Chantilly VA  20151 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Sucralfate suspension
	Trade Name:
	Orphan Designation:
	Treatment of oral complications of chemotherapy in bone marrow 
	transplant patients.
	Designation 
	3/12/1990	Sponsor and Address
	Marketing Exclusivity 	Darby Pharmaceuticals, Inc.
	100 Banks Avenue
	Rockville Centre NY  11570 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sucralfate suspension
	Trade Name:
	Orphan Designation:
	Treatment of oral ulcerations and dysphagia in patients with epidermolysis 
	bullosa.
	Designation 
	3/4/1991	Sponsor and Address
	Marketing Exclusivity 	Darby Pharmaceuticals, Inc.
	100 Banks Avenue
	Rockville Centre NY  11570 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sulfadiazine	Toxoplasmosis, as adjunctive with pyrimethamine
	Trade Name:
	Orphan Designation:
	For use in combination with pyrimethamine for the treatment of 
	Toxoplasma gondii
	Designation 	encephalitis in patients with and without AIDS.
	3/14/1994	Sponsor and Address
	Marketing Exclusivity 	Eon Labs Manufacturing, Inc.
	7/29/1994	227-15 North Conduit Avenue
	Laurelton NY  11413 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sulfapyridine
	Trade Name:
	Orphan Designation:
	Treatment of dermatitis herpetiformis.
	Designation 
	9/10/1990	Sponsor and Address
	Marketing Exclusivity 	Jacobus Pharmaceutical Company
	37 Cleveland Lane
	P.O. Box 5290
	Princeton NJ  08540 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Superoxide dismutase (human)
	Trade Name:
	Orphan Designation:
	For protection of donor organ tissue from damage or injury mediated by 
	oxygen-derived free radicals that are generated during the necessary 
	Designation 	periods of ischemia (hypoxia, anoxia), and especially reperfusion, 
	3/6/1985	associated with the operative procedure.
	Sponsor and Address
	Marketing Exclusivity 	Pharmacia-Chiron Partnership
	4560 Horton Street
	Emeryville CA  94608 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Superoxide dismutase (recombinant human)
	Trade Name:
	Oxsodrol	Orphan Designation:
	Prevention of reperfusion injury to donor organ tissue.
	Designation 
	5/17/1988	Sponsor and Address
	Marketing Exclusivity 	Bio-Technology General Corp.
	70 Wood Avenue, South
	Iselin NJ  08830 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Suramin
	Trade Name:
	Metaret	Orphan Designation:
	Treatment of hormone-refractory prostate cancer.
	Designation 
	5/6/1997	Sponsor and Address
	Marketing Exclusivity 	Warner-Lambert Company
	Parke-Davis Pharmaceutical Research Division
	2800 Plymouth Road
	Ann Arbor MI  48105-2430
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Surface active extract of saline lavage of bovine lungs	Treatment and prevention of respiratory failure due to pulmonary surfactant
	 deficiency in preterm infants.
	Trade Name:
	Infasurf	Orphan Designation:
	Treatment and prevention of respiratory failure due to pulmonary surfactant
	 deficiency in preterm infants.
	Designation 
	6/7/1985	Sponsor and Address
	Marketing Exclusivity 	ONY, Inc.
	1/1/9999	1576 Sweet Home Road
	Amherst NY  14228 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Surfactant (human) (amniotic fluid derived)
	Trade Name:
	Human Surf	Orphan Designation:
	Prevention and treatment of neonatal respiratory distress syndrome.
	Designation 
	3/25/1987	Sponsor and Address
	Marketing Exclusivity 	Merritt, T. Allen M.D.
	2516 Stockton Boulevard
	Sacramento CA  95817 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Synsorb Pk
	Trade Name:
	Orphan Designation:
	Treatment of verocytotoxogenic E. coli infections.
	Designation 
	7/17/1995	Sponsor and Address
	Marketing Exclusivity 	Synsorb Biotech Inc.
	201, 1204 Kensington Road, N.W.
	Calgary, Alberta
	    
	CANADA
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Synthetic Human Parathyroid Hormone 1-34
	Trade Name:
	Orphan Designation:
	Treatment of hypoparathyroidism
	Designation 
	1/26/2001	Sponsor and Address
	Marketing Exclusivity 	Rare Disease Therapeutics, Inc.
	1101 Kermit Drive,
	Suite 608
	Nashville TN  37217 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Synthetic human secretin
	Trade Name:
	Orphan Designation:
	For use in conjunction with diagnostic procedures (including ERCP) for 
	pancreatic disorders to increase pancreatic fluid secretion
	Designation 
	9/18/2006	Sponsor and Address
	Marketing Exclusivity 	Repligen Corporation
	41 Seyon Street
	Waltham MA  02453 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Synthetic human secretin
	Trade Name:
	Orphan Designation:
	For use in the diagnosis of gastrinoma associated with Zollinger-Ellison 
	syndrome.  
	Designation 
	6/16/1999	Sponsor and Address
	Marketing Exclusivity 	ChiRhoClin, Inc.
	15500 Gallaudet Ave.
	Silver Spring MD  20905-4176
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Synthetic human secretin
	Trade Name:
	Orphan Designation:
	For use in conjunction with diagnostic procedures for pancreatic disorders to
	 increase pancreatic fluid secretion.  
	Designation 
	3/7/2000	Sponsor and Address
	Marketing Exclusivity 	ChiRhoClin, Inc.
	15500 Gallaudet Ave.
	Silver Spring MD  20905-4176
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Synthetic human secretin
	Trade Name:
	Orphan Designation:
	For use in obtaining desquamated pancreatic cells for cytopathologic 
	examination in pancreatic carcinoma.
	Designation 
	6/16/1999	Sponsor and Address
	Marketing Exclusivity 	ChiRhoClin, Inc.
	15500 Gallaudet Ave.
	Silver Spring MD  20905-4176
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Synthetic human secretin
	Trade Name:
	Orphan Designation:
	For use in the evaluation of exocrine pancreas function.
	Designation 
	6/16/1999	Sponsor and Address
	Marketing Exclusivity 	ChiRhoClin, Inc.
	1550 Gallaudet Ave.
	Silver Spring MD  20905-4176
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Synthetic porcine secretin
	Trade Name:
	Orphan Designation:
	For use in obtaining desquamated pancreatic cells for cytopathologic 
	examination in pancreatic carcinoma.
	Designation 
	6/18/1999	Sponsor and Address
	Marketing Exclusivity 	ChiRhoClin, Inc.
	15500 Gallaudet Ave.
	Silver Spring MD  20905-4176
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Synthetic porcine secretin	For use in secretin stimulation testing for: Stimulation of pancreatic 
	secretions to facilitate the identification of the ampulla of Vater and 
	accessory papilla during endoscopic retrograde cholangio-pancreatography 
	Trade Name:	(ERCP)
	Orphan Designation:
	For use in the evaluation of exocrine pancreas function.
	Designation 
	6/18/1999	Sponsor and Address
	Marketing Exclusivity 	ChiRhoClin, Inc.
	11/1/2002	15500 Gallaudet Ave.
	Silver Spring MD  20905-4176
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Synthetic porcine secretin	Use in secretin stimulation testing for stimulation of pancreatic secretions, 
	including bicarbonate, to aid in the diagnosis of pancreatic exocrine 
	dysfunction
	Trade Name:
	Orphan Designation:
	For use in conjunction with diagnostic procedures for pancreatic disorders to
	 increase pancreatic fluid secretion.  
	Designation 
	3/7/2000	Sponsor and Address
	Marketing Exclusivity 	ChiRhoClin, Inc.
	4/4/2002	15500 Gallaudet Ave.
	Silver Spring MD  20905-4176
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Synthetic porcine secretin	Use in secretin stimulation testing for stimulation of gastrin secretion to aid 
	in the diagnosis of gastrinoma
	Trade Name:
	Orphan Designation:
	For use in the diagnosis of gastrinoma associated with Zollinger-Ellison 
	syndrome.  
	Designation 
	6/18/1999	Sponsor and Address
	Marketing Exclusivity 	ChiRhoClin, Inc.
	4/4/2002	15500 Gallaudet Ave.
	Silver Spring MD  20905-4176
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	T4 endonuclease V, liposome encapsulated
	Trade Name:
	Orphan Designation:
	To prevent cutaneous neoplasms and other skin abnormalities in xeroderma
	 pigmentosum.
	Designation 
	6/27/1989	Sponsor and Address
	Marketing Exclusivity 	AGI Dermatics
	205 Buffalo Avenue
	Freeport NY  11520 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tacrolimus	Prophylaxis of organ rejection in patients receiving allogenic heart 
	transplants. 
	Trade Name:
	Prograf	Orphan Designation:
	Prophylaxis of organ rejection in patients receiving heart transplants.
	Designation 
	6/6/2005	Sponsor and Address
	Marketing Exclusivity 	Astellas Pharma US, Inc.
	3/29/2006	Three Parkway North
	Deerfield IL  60015-2548
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tacrolimus
	Trade Name:
	Prograf	Orphan Designation:
	Prophylaxis of graft-versus-host-disease.
	Designation 
	4/6/1998	Sponsor and Address
	Marketing Exclusivity 	Fujisawa USA, Inc.
	3 Parkway North Center
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tadalafil
	Trade Name:
	Cialis	Orphan Designation:
	Treatment of pulmonary arterial hypertension
	Designation 
	12/18/2006	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly and Company
	Lilly Corporate Center
	Indianapolis IN  46285 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	TAK-603
	Trade Name:
	Orphan Designation:
	Treatment of Crohn's disease.
	Designation 
	5/13/1998	Sponsor and Address
	Marketing Exclusivity 	Tap Holdings Inc.
	2355 Waukegan Road
	Deerfield IL  60015 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Talactoferrin alfa
	Trade Name:
	Orphan Designation:
	Treatment of non-small cell lung cancer
	Designation 
	8/8/2007	Sponsor and Address
	Marketing Exclusivity 	Agennix, Inc.
	8 Greenway Plaza
	Houston TX  77046 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	talactoferrin alfa
	Trade Name:
	Orphan Designation:
	Treatment of renal cell carcinoma
	Designation 
	9/29/2006	Sponsor and Address
	Marketing Exclusivity 	Agennix, Inc.
	8 Greenway Plaza
	Suite 910
	Houston TX  77046 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	talactoferrin alfa
	Trade Name:
	Orphan Designation:
	For the treatment of graft versus host disease
	Designation 
	8/20/2003	Sponsor and Address
	Marketing Exclusivity 	Agennix, Inc.
	Greenway Plaza
	Suite 910
	Houston TX  77046 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	talactoferrin alfa
	Trade Name:
	Orphan Designation:
	For the prevention of graft-versus-host disease
	Designation 
	8/20/2003	Sponsor and Address
	Marketing Exclusivity 	Agennix, Inc.
	8 Greenway Plaza
	Suite 910
	Houston TX  77046 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	talampanel
	Trade Name:
	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis 
	Designation 
	3/24/2008	Sponsor and Address
	Marketing Exclusivity 	TEVA Neuroscience
	P. O. Box 1005
	Horsham PA  19044-8005
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Talotrexin
	Trade Name:
	Orphan Designation:
	Treatment of acute lymphoblastic leukemia
	Designation 
	5/8/2006	Sponsor and Address
	Marketing Exclusivity 	Hana Biosciences, Inc.
	7000 Shoreline Court
	Suite 370
	South San Francisco CA  94080 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tamibarotene
	Trade Name:
	Orphan Designation:
	Treatment of acute promyelocytic leukemia (APL).
	Designation 
	10/11/2007	Sponsor and Address
	Marketing Exclusivity 	Innovive Pharmaceuticals
	555 Madison Avenue
	New York NY  10022 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tanespimycin
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	9/9/2004	Sponsor and Address
	Marketing Exclusivity 	Kosan Biosciences, Inc
	3832 Bay Center Place
	Hayward CA  94545 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	T-cell depleted stem cell enriched cellular product 
	from peripheal b
	lood stem cells
	Trade Name:
	Orphan Designation:
	Treatment of chronic granulomatous disease
	Designation 
	11/1/2001	Sponsor and Address
	Marketing Exclusivity 	Nexell Therapeutics Inc.
	9 Parker
	Irvine CA  92618-1605
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	TD-K6a.513a.12
	Trade Name:
	ReveKer	Orphan Designation:
	Treatment of pachyonychia congenita
	Designation 
	6/15/2006	Sponsor and Address
	Marketing Exclusivity 	TransDerm, Inc.
	2161 Delaware Aenue
	Santa Cruz CA  95060 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Technetium Tc 99m pterotetramide
	Trade Name:
	Orphan Designation:
	For the identification of ovarian carcinomas.
	Designation 
	2/16/2000	Sponsor and Address
	Marketing Exclusivity 	Endocyte, Inc.
	1205 Kent Ave.
	West Lafayette IN  47906 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Technetium Tc99m anti-melanoma murine 
	monoclonal antibody
	Trade Name:
	Oncotrac Melanoma Imaging Kit	Orphan Designation:
	For use in detecting, by imaging, metastases of malignant melanoma.
	Designation 
	6/2/1987	Sponsor and Address
	Marketing Exclusivity 	NeoRx Corporation
	410 West Harrison
	Seattle WA  98119-4007
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Technetium Tc99m murine monoclonal antibody 
	(IgG2a) to B cell
	Trade Name:
	LymphoScan	Orphan Designation:
	Diagnostic imaging in the evaluation of the extent of disease in patients 
	with histologically confirmed diagnosis of non-Hodgkin's B-cell lymphoma, 
	Designation 	acute B-cell lymphoblastic leukemia (in children and adults), and chronic B-
	4/7/1992	cell lymphocytic leukemia.
	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Technetium Tc99m murine monoclonal antibody to 
	hCG
	Trade Name:
	Immuraid, hCG-Tc-99m	Orphan Designation:
	Detection of hCG producing tumors such as germ cell and trophoblastic cell
	 tumors.
	Designation 
	8/7/1989	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Technetium Tc99m murine monoclonal antibody to 
	human AFP
	Trade Name:
	AFP-Scan	Orphan Designation:
	Detection of alpha-fetoprotein producing germ cell tumors.
	Designation 
	8/1/1989	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Technetium Tc99m murine monoclonal antibody to 
	human alpha-fetoprotein
	Trade Name:
	Immuraid, AFP-Scan	Orphan Designation:
	Detection of hepatocellular carcinoma and hepatoblastoma.
	Designation 
	8/1/1989	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Road
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Technetium Tc99m rh-Annexin V
	Trade Name:
	Apomate	Orphan Designation:
	Diagnosis or assessment of rejection status in heart, heart-lung, single lung, 
	or bilateral lung transplants.
	Designation 
	11/3/2000	Sponsor and Address
	Marketing Exclusivity 	Theseus Imaging Corporation
	124 Mount Auburn Street
	Suite 200 North
	Cambridge MA  02138 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tegafur/gimeracil/oteracil
	Trade Name:
	Orphan Designation:
	Treatment of gastric cancer
	Designation 
	7/20/2006	Sponsor and Address
	Marketing Exclusivity 	Taiho Pharma USA, Inc.
	210 Carnegie Center
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	temocillin sodium
	Trade Name:
	Negaban	Orphan Designation:
	Treatment of pulmonary infections caused by Burkholderia cepacia
	Designation 
	4/21/2004	Sponsor and Address
	Marketing Exclusivity 	Belpharma N.V.
	67 Winston Churchill Avenue
	Brussels    
	 
	BELGIUM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Temoporfin
	Trade Name:
	Foscan	Orphan Designation:
	Palliative treatment of recurrent, refractory or second primary squamous cell
	 carcinomas of the head and neck in patients considered to be incurable 
	Designation 	with surgery or radiotherapy.  
	10/28/1999	Sponsor and Address
	Marketing Exclusivity 	Biolitec Pharma Ireland Ltd.
	United Drug House
	Dublin
	    
	IRELAND
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	temozolomide	Treatment of adult patients with newly diagnosed glioblastoma multiforme 
	concomitatly with radiotherapy and then as maintenance treatment
	Trade Name:
	Temodar	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	10/5/1998	Sponsor and Address
	Marketing Exclusivity 	Schering-Plough Reasearch Institute
	3/15/2005	2000 Galloping Hill Rd.
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Temozolomide
	Trade Name:
	Temodal	Orphan Designation:
	Treatment of newly diagnosed high grade glioma
	Designation 
	10/18/2004	Sponsor and Address
	Marketing Exclusivity 	Schering-Plough Research Institute
	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Temozolomide
	Trade Name:
	Temodal	Orphan Designation:
	Treatment of advanced metastatic melanoma.
	Designation 
	10/14/1998	Sponsor and Address
	Marketing Exclusivity 	Schering-Plough Research Institute
	2000 Galloping Hill Rd.
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Temozolomide	Treatment of adult patients with refractory anaplastic astrocytoma, i.e., 
	patients at first relapse who have experienced disease progression on a 
	drug regimen containing a nitrosourea and procarbazine.
	Trade Name:
	Temodar	Orphan Designation:
	Treatment of recurrent malignant glioma.  
	Designation 
	10/5/1998	Sponsor and Address
	Marketing Exclusivity 	Schering-Plough Research Institute
	8/11/1999	2000 Galloping Hill Rd.
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Temsirolimus	Treatment of advanced renal cell carcinoma
	Trade Name:
	Torisel	Orphan Designation:
	Treatment of renal cell carcinoma
	Designation 
	12/16/2004	Sponsor and Address
	Marketing Exclusivity 	Wyeth Pharmaceuticals, Inc.
	5/30/2007	P. O. Box 8299
	Phildelphia PA  19101-8299
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Teniposide	Induction therapy in patients with refractory childhood acute lymphoblastic 
	leukemia when used in combination with other approved anticancer agents.
	Trade Name:
	Vumon for injection	Orphan Designation:
	Treatment of refractory childhood acute lymphocytic leukemia.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	7/14/1992	5 Research Parkway
	P.O. Box 5100
	Wallingford CT  06492 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	terguride
	Trade Name:
	Orphan Designation:
	Treatment of pulmonary arterial hypertension.
	Designation 
	5/1/2008	Sponsor and Address
	Marketing Exclusivity 	ErgoNex Pharma GmbH
	Ruetistr. 20
	CH-9050 Appenzell
	    
	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Teriparatide
	Trade Name:
	Parathar	Orphan Designation:
	Diagnostic agent to assist in establishing the diagnosis in patients 
	presenting with clinical and laboratory evidence of hypocalcemia due to 
	Designation 	either hypoparathyroidism or pseudohypoparathyroidism.
	1/9/1987	Sponsor and Address
	Marketing Exclusivity 	Rhone-Poulenc Rorer Pharmaceuticals, Inc.
	12/23/1987	500 Arcola Road
	Collegeville PA  19426 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Teriparatide
	Trade Name:
	Parathar	Orphan Designation:
	Treatment of idiopathic osteoporosis.
	Designation 
	10/28/1999	Sponsor and Address
	Marketing Exclusivity 	Henri Beaufour Institute USA, Inc.
	27 Maple St.
	Milford MA  01757 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Terlipressin
	Trade Name:
	Glypressin	Orphan Designation:
	Treatment of bleeding esophageal varices.
	Designation 
	3/6/1986	Sponsor and Address
	Marketing Exclusivity 	Ferring Laboratories, Inc.
	400 Rella Boulevard, Suite 201
	Suffern NY  10901 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Terlipressin (INN)	Fast Track granted by CDER.  A rolling NDA submission is planned by the 
	sponsor.
	Trade Name:
	Orphan Designation:
	Treatment of Hepatorenal Syndrome
	Designation 
	10/29/2004	Sponsor and Address
	Marketing Exclusivity 	Orphan Therapeutics, LLC
	3 Werner Way
	Round Valley Executive Center
	Lebanon NJ  08833 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Testosterone
	Trade Name:
	Androgel	Orphan Designation:
	Treatment of weight loss in AIDS patients with HIV-associated wasting.
	Designation 
	2/5/1996	Sponsor and Address
	Marketing Exclusivity 	Unimed Pharmaceuticals, Inc.
	901 Sawyer Rd.
	Marietta  GA  30062 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Testosterone
	Trade Name:
	TheraDerm Testosterone Transdermal System	Orphan Designation:
	For use as physiologic testosterone replacement in androgen deficient HIV+
	 patients with an associated weight loss.
	Designation 
	9/22/1997	Sponsor and Address
	Marketing Exclusivity 	Watson Laboratories
	Research Park
	417 Wakara Way
	Salt Lake City UT  84108 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Testosterone propionate ointment 2%
	Trade Name:
	Orphan Designation:
	Treatment of vulvar dystrophies.
	Designation 
	7/31/1991	Sponsor and Address
	Marketing Exclusivity 	Star Pharmaceuticals, Inc.
	1990 N.W. 44th Street
	Pompano Beach FL  33064 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Testosterone sublingual
	Trade Name:
	Orphan Designation:
	Treatment of constitutional delay of growth and puberty in boys.
	Designation 
	1/16/1991	Sponsor and Address
	Marketing Exclusivity 	Bio-Technology General Corp.
	70 Wood Avenue South
	Iselin NJ  08830 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Tetrabenazine
	Trade Name:
	Xenazine	Orphan Designation:
	Treatment of Huntington's disease.
	Designation 
	12/11/1997	Sponsor and Address
	Marketing Exclusivity 	Prestwick Pharmaceuticals, Inc
	1825 K Street NW
	Suite 1475
	Washington DC  20006 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tetrabenazine
	Trade Name:
	Orphan Designation:
	Treatment of moderate/severe tardive dyskinesia.
	Designation 
	5/12/1998	Sponsor and Address
	Marketing Exclusivity 	Prestwick Pharmaceuticals, Inc.
	1825 K Street, NW
	Suite 1475
	Washington DC  20006 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tetraiodothyroacetic acid
	Trade Name:
	Orphan Designation:
	Suppression of thyroid stimulating hormone in patients with well-
	differentiated cancer of the thyroid gland.
	Designation 
	5/1/2000	Sponsor and Address
	Marketing Exclusivity 	Danforth, Jr., MD, Elliot
	University of Vermont
	84 Beartown Rd.
	Underhill VT  05489 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tezacitabine
	Trade Name:
	Orphan Designation:
	Treatment of adenocarcinoma of the esophagus and stomach
	Designation 
	1/27/2003	Sponsor and Address
	Marketing Exclusivity 	Sanofi-Aventis Pharma
	9 Great valley Parkway
	Malvern PA  19355-1304
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	TGF(beta)2-specific phosphorothioate antisense 
	oligodeoxynucleotide
	Trade Name:
	Oncomun	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	6/5/2002	Sponsor and Address
	Marketing Exclusivity 	Antisense Pharma GmbH
	Josef-Engert-Str. 9
	93053 Regensberg
	    
	GERMANY
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	TGp1PTH1-34
	Trade Name:
	Orphan Designation:
	Treatment of solitary (unicameral) bone cysts.
	Designation 
	2/1/2007	Sponsor and Address
	Marketing Exclusivity 	Kuros Biosurgery AG
	Technoiparkstrasse 1
	Zurich    
	 
	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide 
	Trade Name:
	Thalomid	Orphan Designation:
	Treatment of Myelodysplastic Syndrome 
	Designation 
	9/27/2004	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	86 Morris Avenue
	Summit NJ  07901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Orphan Designation:
	Treatment and prevention of recurrent aphthous ulcers in severely, 
	terminally immunocompromised patients.
	Designation 
	5/15/1995	Sponsor and Address
	Marketing Exclusivity 	Andrulis Research Corporation
	11800 Baltimore Avenue, Suite 113
	Beltsville MD  20705 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Synovir	Orphan Designation:
	Treatment of HIV-associated wasting syndrome.
	Designation 
	3/11/1996	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	P.O. Box 4914
	7 Powder Horn Drive
	Warren NJ  07059 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Thalomid	Orphan Designation:
	Treatment of Crohn's disease.
	Designation 
	4/6/1999	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	7 Powder Horn Dr.
	Warren NJ  07059 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Orphan Designation:
	Prevention of graft versus host disease in patients receiving bone marrow 
	transplantation.
	Designation 
	9/19/1988	Sponsor and Address
	Marketing Exclusivity 	Pediatric Pharmaceuticals, Inc.
	718 Bradford Avenue
	Westfield NJ  07090 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Orphan Designation:
	Treatment of graft versus host disease in patients receiving bone marrow 
	transplantation.
	Designation 
	9/19/1988	Sponsor and Address
	Marketing Exclusivity 	Pediatric Pharmaceuticals, Inc.
	718 Bradford Avenue
	Westfield NJ  07090 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Orphan Designation:
	Treatment and maintenance of reactional lepromatous leprosy.
	Designation 
	11/15/1988	Sponsor and Address
	Marketing Exclusivity 	Pediatric Pharmaceuticals, Inc.
	718 Bradford Avenue
	Westfield NJ  07090 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Orphan Designation:
	Treatment of the clinical manifestations of mycobacterial infection caused 
	by Mycobacterium tuberculosis and non-tuberculous mycobacteria.
	Designation 
	1/12/1993	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	P.O. Box 4914
	7 Powder Horn Drive
	Warren NJ  07059 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Orphan Designation:
	Prevention of graft versus host disease.
	Designation 
	3/5/1990	Sponsor and Address
	Marketing Exclusivity 	Andrulis Research Corporation
	11800 Baltimore Avenue, Suite 113
	Beltsville MD  20705 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Orphan Designation:
	Treatment of graft versus host disease.
	Designation 
	3/5/1990	Sponsor and Address
	Marketing Exclusivity 	Andrulis Research Corporation
	11800 Baltimore Avenue, Suite 113
	Beltsville MD  20705 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Orphan Designation:
	Treatment of primary brain malignancies.
	Designation 
	2/27/1998	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	7 Powder Horn Dr.
	Warren NJ  07059 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Orphan Designation:
	Treatment of severe recurrent aphthous stomatitis in severely, terminally 
	immunocompromised patients.
	Designation 
	5/1/1995	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	P.O. Box 4914
	7 Powder Horn Srive
	Warren NJ  07059 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide	Acute treatment of the cutaneous manifestations of moderate to severe 
	erythema nodosum leprosum (ENL) and as maintenance therapy for 
	prevention and suppression of the cutaneous manifestations of ENL 
	Trade Name:	recurrences.
	Thalomid	Orphan Designation:
	Treatment of erythema nodosum leprosum.
	Designation 
	7/26/1995	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	7/16/1998	86 Morris Avenue
	Summit NJ  07901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide
	Trade Name:
	Orphan Designation:
	Treatment of Kaposi's sarcoma.
	Designation 
	7/29/1998	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	7 Powder Horn Dr.
	Warren NJ  07059 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Thalidomide	Treatment of patients with newly diagnosed multiple myeloma
	Trade Name:
	Thalomid	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	10/14/1998	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	5/25/2006	7 Powder Horn Dr.
	Warren NJ  07059 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thiotepa
	Trade Name:
	Tepadina	Orphan Designation:
	Conditioning treatment prior to hematopoietic stem cell transplantation
	Designation 
	4/2/2007	Sponsor and Address
	Marketing Exclusivity 	Adienne S.r.l.
	24128 Bergamo, 64/B Broseta Street
	Bergamo    
	 
	ITALY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thymalfasin
	Trade Name:
	Zadaxin	Orphan Designation:
	Treatment of stage IIb through Stage IV malignant melanoma
	Designation 
	3/13/2006	Sponsor and Address
	Marketing Exclusivity 	SciClone Pharmaceuticals, Inc.
	901 Mariner's Island Blvd
	San Mateo CA  94404 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thymalfasin
	Trade Name:
	Zadaxin	Orphan Designation:
	Treatment of chronic active hepatitis B.
	Designation 
	5/3/1991	Sponsor and Address
	Marketing Exclusivity 	SciClone Pharmaceuticals, Inc.
	950 Tower Lane
	Suite 900
	Foster City CA  94404-2125
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thymalfasin
	Trade Name:
	Zadaxin	Orphan Designation:
	Treatment of DiGeorge anomaly with immune defects.
	Designation 
	1/8/1998	Sponsor and Address
	Marketing Exclusivity 	SciClone Pharmaceuticals, Inc.
	901 Mariner's Island Blvd.
	San Mateo CA  94404-1593
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Thymalfasin
	Trade Name:
	Zadaxin	Orphan Designation:
	Treatment of hepatocellular carcinoma.  
	Designation 
	3/6/2000	Sponsor and Address
	Marketing Exclusivity 	SciClone Pharmaceuticals, Inc.
	901 Mariner's Blvd., Suite 205
	San Mateo CA  94404-1593
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thymosin beta 4
	Trade Name:
	Orphan Designation:
	Treatment of epidermolysis bullosa
	Designation 
	5/28/2004	Sponsor and Address
	Marketing Exclusivity 	RegeneRx Biopharmaceuticals, Inc.
	3 Bethesda Metro Center
	Suite 700
	Bethesda MD  20814 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thymoxamine HCl
	Trade Name:
	Orphan Designation:
	Reversal of phenylephrine-induced mydriasis in patients who have narrow 
	anterior angles and are at risk of developing an acute attack of angle-
	Designation 	closure glaucoma following mydriasis.
	11/16/1987	Sponsor and Address
	Marketing Exclusivity 	Iolab Pharmaceuticals
	500 Iolab Drive
	Claremont CA  91711 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thyrotropin alfa	For use as an adjunctive treatment for radioiodine ablation of thyroid tissue 
	remnants in patients who have undergone thyroidectomy for well-
	differentiated thyroid cancer and who do not have evidence of metastatic 
	Trade Name:	thyroid cancer
	Thyrogen	Orphan Designation:
	Treatment of well-differentiated papillary, follicular or combined 
	papillary/follicular carcinomas of the thyroid
	Designation 
	8/3/2001	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	12/14/2007	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thyrotropin alpha	As an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or 
	without radioiodine imaging in the follow-up of patients with thyroid cancer.
	Trade Name:
	Thyrogen	Orphan Designation:
	As an adjunct in the diagnosis of thyroid cancer.
	Designation 
	2/24/1992	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	11/30/1998	One Kendall Square
	Cambridge MA  02139 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Tiapride
	Trade Name:
	Orphan Designation:
	Treatment of Tourette's syndrome.
	Designation 
	4/21/1998	Sponsor and Address
	Marketing Exclusivity 	Sanofi-Synthelabo, Inc.
	9 Great Valley Parkway
	PO Box 3026
	Malvern PA  19355 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tiazofurin (2-Beta-D-ribofuranosyl-4-
	thiazolecarboxamide)
	Trade Name:
	Orphan Designation:
	Chronic myelogenous leukemia (CML)
	Designation 
	12/27/2000	Sponsor and Address
	Marketing Exclusivity 	Valeant Research & Development
	3300 Hyland Avenue
	Costa Mesa CA  92626 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tilarginine acetate
	Trade Name:
	Orphan Designation:
	Treatment of cardiogenic shock 
	Designation 
	4/11/2005	Sponsor and Address
	Marketing Exclusivity 	Arginox Pharmceuticals, Inc.
	120 Constitution Drive
	Menlo Park CA  94025 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	tin ethyl etiopurpurin
	Trade Name:
	Orphan Designation:
	Prevention of access graft disease in hemodialysis patients
	Designation 
	11/4/2003	Sponsor and Address
	Marketing Exclusivity 	Miravant Medical Technologies
	336 Bollay Drive
	Goleta CA  93117 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	tinidazole	Treatment of giardiasis caused by G. duodenalis (also termed G. lamblia) 
	in both adults and pediatric patients older than three years of age
	Trade Name:
	Tindamax	Orphan Designation:
	Treatment of giardiasis
	Designation 
	4/18/2002	Sponsor and Address
	Marketing Exclusivity 	Presutti Laboratories, Inc.
	5/17/2004	1607 N. Douglas Ave.
	Arlington Heights IL  60004 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Tinidazole	Treatment of intestinal amebiasis and amebic liver abcess caused by E. 
	histolytica in both adults and pediatric patients older than three years of 
	age.  It is not indicated for the treatment of asymptomatic cyst passage.
	Trade Name:
	Tindamax	Orphan Designation:
	Treatment of amebiasis
	Designation 
	8/20/2003	Sponsor and Address
	Marketing Exclusivity 	Presutti Laboratories, Inc.
	5/17/2004	1607 N. Douglas Avenue
	Arlington Heights IL  60004 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tiopronin
	Trade Name:
	Thiola	Orphan Designation:
	Prevention of cystine nephrolithiasis in patients with homozygous cystinuria.
	Designation 
	1/17/1986	Sponsor and Address
	Marketing Exclusivity 	Pak, Charles Y.C. M.D.
	8/11/1988	The University of Texas Health Scienc Center at Da
	5323 Harry Hines Boulevard
	Dallas TX  75235 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tiotropium bromide
	Trade Name:
	Spiriva	Orphan Designation:
	To improve pulmonary function in conjunction with standard therapy in the 
	management of patients with cystic fibrosis
	Designation 
	1/8/2008	Sponsor and Address
	Marketing Exclusivity 	Boehringer Ingelheim Pharmaceuticals, Inc.
	P. O. Box 368
	900 Ridgebury Road
	Ridgefield CT  06877 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tipifarnib
	Trade Name:
	Zarnestra	Orphan Designation:
	Treatment of acute myeloid leukemia  
	Designation 
	7/6/2004	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical Research & Dev.
	920 U.S. Highway 202
	Raritan NJ  08869 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	tirapazamine
	Trade Name:
	Orphan Designation:
	Treatment of head and neck cancer
	Designation 
	10/23/2002	Sponsor and Address
	Marketing Exclusivity 	Sanofi-Aventis US, Inc.
	11 Great Valley Parkway
	P. O. Box 3026
	Malvern PA  19355 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Tiratricol
	Trade Name:
	Triacana	Orphan Designation:
	For use in combination with levo-thyroxine to suppress thyroid stimulating 
	hormone in patients with well-differentiated thyroid cancer who are 
	Designation 	intolerant to adequate doses of levo-thyroxine alone.
	8/13/1991	Sponsor and Address
	Marketing Exclusivity 	Laphal Laboratoires
	48 Bis, Rue des Belles-Feuilles
	75116 Paris
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tissue repair cells obtained from autologous bone 
	marrow expanded ex vivo with a cell production system
	Trade Name:
	Orphan Designation:
	Treatment of osteonecrosis
	Designation 
	3/13/2006	Sponsor and Address
	Marketing Exclusivity 	Aastrom Biosciences, Inc.
	Domino's Farms
	24 Frank Lloyd Wright Drive
	Ann Arbor MI  48105 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tissue repair cells obtained from autologous bone 
	marrow expanded ex vivo with a cell production system
	Trade Name:
	Orphan Designation:
	Treatment of dilated cardiomyopathy
	Designation 
	1/25/2007	Sponsor and Address
	Marketing Exclusivity 	Aastrom Biosciences, Inc.
	Domino's Farms, Lobby L
	Ann Arbor MI  48105 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Titanium dioxide and bisoctrizole
	Trade Name:
	Orphan Designation:
	For the secondary prevention (prevention of lesional induction) of disorders 
	with UV-A and visible light-induced photosensitivity, specifically Actinic 
	Designation 	prurigo, Hydroa vacciniforme, Solar urticara (SU), Chronic Actinic Dermatitis
	5/25/2005	 (CAD), the cutaneous prophyrias, Smith-Lemli-Optiz Syndrome, and 
	Sponsor and Address
	Marketing Exclusivity 	Orfagen
	Parc Technologique Du Canal-4
	31521 Ramonville Saint Agne
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tizanidine HCl	For the acute and intermittent management of increased muscle tone 
	associated with spasticity. 
	Trade Name:
	Zanaflex	Orphan Designation:
	Treatment of spasticity associated with multiple sclerosis and spinal cord 
	injury.
	Designation 
	1/31/1994	Sponsor and Address
	Marketing Exclusivity 	Athena Neurosciences, Inc.
	800 Gateway Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Tobramycin
	Trade Name:
	Tobi	Orphan Designation:
	Treatment of bronchiectasis patients infected with Pseudomonas 
	aeruginosa.
	Designation 
	6/18/1999	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corp.
	Drug Regulatory Affairs
	One Health Plaza
	East Hanover NJ  07936-1080
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tobramycin for inhalation	Management of cystic fibrosis patients with P.aeruginosa.
	Trade Name:
	TOBI	Orphan Designation:
	Treatment of bronchopulmonary infections of Pseudomonas aeruginosa in 
	cystic fibrosis patients.
	Designation 
	10/13/1994	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corp
	12/22/1997	Drug Regulatory Affairs
	One Health Plaza
	East Hanover NJ  07936-1080
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tocophersolan oral  solution (vitamin E-tpgs)
	Trade Name:
	Orphan Designation:
	Treatment of vitamin E deficiency resulting from malabsorption due to 
	prolonged cholestatic hepatobiliary disease.
	Designation 
	4/15/1988	Sponsor and Address
	Marketing Exclusivity 	Sterling Winthrop
	9 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Topiramate	As adjunctive therapy in patients two years and older with siezures 
	associated with Lennox-Gastaut syndrome.
	Trade Name:
	Topamax	Orphan Designation:
	Treatment of Lennox-Gastaut syndrome.
	Designation 
	11/25/1992	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical R & D, LLC
	8/28/2001	Route 202, P.O. Box 300
	Raritan NJ  08869-0602
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	toralizumab
	Trade Name:
	Orphan Designation:
	Treatment of immune thrombocytopenic purpura
	Designation 
	3/14/2002	Sponsor and Address
	Marketing Exclusivity 	Biogen IDEC Inc.
	3030 Callan Road
	San Diego CA  92121 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Toremifene
	Trade Name:
	Orphan Designation:
	Treatment of desmoid tumors.
	Designation 
	8/17/1993	Sponsor and Address
	Marketing Exclusivity 	Orion Corporation
	P.O. Box 65
	02101 Espoo
	    
	FINLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Toremifene	Treatment of metastatic breast cancer in postmenopausal women with 
	estrogen positive or receptor unknown tumors.
	Trade Name:
	Fareston	Orphan Designation:
	Hormonal therapy of metastatic carcinoma of the breast.
	Designation 
	9/19/1991	Sponsor and Address
	Marketing Exclusivity 	Orion Corporation
	5/29/1997	P.O. Box 65
	02101 ESPOO
	    
	FINLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tositumomab and iodine I 131 tositumomab	Treatment of patients with CD20 positive, follicular, non-Hodgkin's 
	lymphoma, with and without transformation, whose disease is refractory to 
	Rituximab and has relapsed following chemotherapy
	Trade Name:
	Bexxar	Orphan Designation:
	Treatment of non-Hodgkin's B-cell lymphoma.
	Designation 
	5/16/1994	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline
	6/27/2003	2301 Renaissance Blv.
	P.O. Box 61540
	King of Prussia PA  19406-2772
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	trabectedin
	Trade Name:
	Yondelis	Orphan Designation:
	Treatment of soft tissue sarcoma.
	Designation 
	9/30/2004	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical Research & Dev.
	920 US Highway 202
	Raritan NJ  08869 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	trabectedin
	Trade Name:
	Yondelis	Orphan Designation:
	Treatment of patients with epithelial ovarian cancer
	Designation 
	3/29/2005	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical Research  & Dev.
	920 U S Highway 202
	Raritan NJ  08869 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Tramadol hydrochloride
	Trade Name:
	Orphan Designation:
	Management of postherpetic neuralgia
	Designation 
	4/26/2005	Sponsor and Address
	Marketing Exclusivity 	TheraQuest Biosciences, LLC
	146 Medinah Drive
	Blue Bell PA  19422-3212
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tramadol hydrochloride
	Trade Name:
	Orphan Designation:
	Treatment of painful HIV-associated neuropathy
	Designation 
	1/28/2005	Sponsor and Address
	Marketing Exclusivity 	TheraQuest Biosciences, LLC
	146 Medinah Drive
	Blue Bell PA  19422-3212
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tranexamic acid
	Trade Name:
	Cyklokapron	Orphan Designation:
	Treatment of patients with congenital coagulopathies who are undergoing 
	surgical procedures (e.g. dental extractions).
	Designation 
	10/29/1985	Sponsor and Address
	Marketing Exclusivity 	Pharmacia Inc.
	12/30/1986	P.O. Box 16529
	Columbus OH  43216 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tranexamic acid
	Trade Name:
	Cyklokapron	Orphan Designation:
	Treatment of patients undergoing prostatectomy where there is hemorrhage
	 or risk of hemorrhage as a result of increased fibrinolysis or fibrinogenolysis.
	Designation 
	7/23/1987	Sponsor and Address
	Marketing Exclusivity 	Pharmacia Inc.
	P.O. Box 16529
	Columbus OH  43216 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tranexamic acid
	Trade Name:
	Cyklokapron	Orphan Designation:
	Treatment of hereditary angioneurotic edema.
	Designation 
	9/9/1985	Sponsor and Address
	Marketing Exclusivity 	Pharmacia Inc.
	P.O. Box 16529
	Columbus OH  43216 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Tranilast
	Trade Name:
	Rizaben	Orphan Designation:
	For the treatment of maligant glioma
	Designation 
	12/2/2003	Sponsor and Address
	Marketing Exclusivity 	Angiogen Pharmaceuticals, Pty. Ltd.
	Level 31, ABN AMRO Tower
	88 Phillip Street    Sydney, N.S.W. 2000
	    
	AUSTRALIA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Transforming growth factor-beta 2
	Trade Name:
	Orphan Designation:
	Treatment of full thickness macular holes.
	Designation 
	12/18/1992	Sponsor and Address
	Marketing Exclusivity 	Celtrix Pharmaceuticals, Inc.
	3055 Patrick Henry Drive
	Santa Clara CA  95054 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Transgenic human alpha 1 antitrypsin
	Trade Name:
	Orphan Designation:
	Treatment of emphysema secondary to alpha 1 antitrypsin deficiency.  
	Designation 
	5/19/1999	Sponsor and Address
	Marketing Exclusivity 	PPL Therapeutics (Scotland) Limited
	Roslin, Edinburgh
	EH259PP Scotland
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trastuzumab
	Trade Name:
	Herceptin	Orphan Designation:
	Treatment of patients with pancreatic cancer that overexpress p185HER2.  
	Designation 
	12/14/1999	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1 DNA Way
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Treosulfan
	Trade Name:
	Ovastat	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	5/16/1994	Sponsor and Address
	Marketing Exclusivity 	Medac GmbH
	Fehlandtstrasse 3
	D-20354 Hamburg
	    
	GERMANY
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	treprostinil	Treatment of pulmonary arterial hypertension.
	Trade Name:
	Remodulin	Orphan Designation:
	Treatment of pulmonary arterial hypertension.
	Designation 
	6/4/1997	Sponsor and Address
	Marketing Exclusivity 	United Therapeutics Corp.
	5/21/2002	68 T.W. Alexander Dr.
	P.O. Box 14186
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tretinoin	Induction of remission in patients with acute promyelocytic leukemia who 
	are refractory to or unable to tolerate anthracycline based cytotoxic 
	chemotherapeutic regimens.
	Trade Name:
	Vesanoid	Orphan Designation:
	Treatment of acute promyelocytic leukemia.
	Designation 
	10/24/1990	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	11/22/1995	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tretinoin
	Trade Name:
	ATRA-IV	Orphan Designation:
	Treatment of acute and chronic leukemia.
	Designation 
	1/14/1993	Sponsor and Address
	Marketing Exclusivity 	Antigenics, Inc.
	3 Forbes Road
	Lexington MA  02421 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tretinoin
	Trade Name:
	ATRA-IV	Orphan Designation:
	Treatment of T-cell  non-Hodgkin's lymphoma
	Designation 
	4/11/2003	Sponsor and Address
	Marketing Exclusivity 	Antigenics, Inc.
	3 Forbes Road
	Lexington MA  02421 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tretinoin
	Trade Name:
	Orphan Designation:
	Treatment of squamous metaplasia of the ocular surface epithelia 
	(conjunctiva and/or cornea) with mucous deficiency and keratinization.
	Designation 
	4/15/1985	Sponsor and Address
	Marketing Exclusivity 	Hannan Ophthalmic Marketing Services, Inc
	34 Sherrill Rd.
	Marshfield MA  02050 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	tri-antennary glycotripeptide derivative of 5-
	fluorodeoxyuridine monophosphate
	Trade Name:
	Orphan Designation:
	Treatment for hepatocellular carcinoma
	Designation 
	11/23/2001	Sponsor and Address
	Marketing Exclusivity 	Cell Works Inc.
	6200 Seaforth Street
	Baltimore MD  21224-6506
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	triciribine
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	2/1/2008	Sponsor and Address
	Marketing Exclusivity 	VioQuest Pharmaceuticals, Inc.
	180 Mt. Airy Road
	Basking Ridge NJ  07920 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trientine HCl
	Trade Name:
	Syprine	Orphan Designation:
	Treatment of patients with Wilson's disease who are intolerant, or 
	inadequately responsive to penicillamine.
	Designation 
	12/24/1984	Sponsor and Address
	Marketing Exclusivity 	Merck Sharp & Dohme Research
	11/8/1985	Division Of Merck And Company
	West Point PA  19486 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Triheptanoin
	Trade Name:
	Triheptanoin-SASOL Special Oil	Orphan Designation:
	Treatment of glycogen storage disorder II (Pompe disease)
	Designation 
	2/1/2008	Sponsor and Address
	Marketing Exclusivity 	Baylor Research Institute
	3330 Live Oak Blvd
	Dallas TX  75204 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Triheptanoin
	Trade Name:
	Triheptanoim-SASOl Special Oil	Orphan Designation:
	Treatment of fatty acid disorders
	Designation 
	5/26/2006	Sponsor and Address
	Marketing Exclusivity 	Baylor Research Institute
	Institute of Metabolic Disease
	3812 Elm Street
	Dallas TX  75226 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Trimetrexate
	Trade Name:
	Neutrexin	Orphan Designation:
	Treatment of metastatic osteogenic sarcoma.
	Designation 
	8/10/2000	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trimetrexate glucuronate
	Trade Name:
	Orphan Designation:
	Treatment of patients with advanced non-small cell carcinoma of the lung.
	Designation 
	1/13/1988	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trimetrexate glucuronate	Concurrent leucovorin administration as an alternative therapy for the 
	treatment of moderate to severe PCP in immunocompromised patients who
	 are intolerant of, or are refractory to, trimethoprim sulfamethoxazole.
	Trade Name:
	Neutrexin	Orphan Designation:
	Treatment of Pneumocystis carinii pneumonia in AIDS patients.
	Designation 
	5/15/1986	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	12/17/1993	One Tower Bridge
	100 Front Street, Suite 400
	West Conshohocken PA  19428 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trimetrexate glucuronate
	Trade Name:
	Orphan Designation:
	Treatment of pancreatic adenocarcinoma.
	Designation 
	7/25/1985	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trimetrexate glucuronate
	Trade Name:
	Orphan Designation:
	Treatment of metastatic colorectal adenocarcinoma.
	Designation 
	7/25/1985	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Trimetrexate glucuronate
	Trade Name:
	Orphan Designation:
	Treatment of metastatic carcinoma of the head and neck (i.e. buccal cavity,
	 pharynx, and larynx).
	Designation 
	7/25/1985	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	One MedImmune Way
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Triptorelin pamoate
	Trade Name:
	Decapeptyl Injection	Orphan Designation:
	For use in the palliative treatment of advanced ovarian carcinoma of 
	epithelial origin.
	Designation 
	8/10/1990	Sponsor and Address
	Marketing Exclusivity 	Debio R.A. Inc.
	7929 Westpark Drive, Suite 400
	Mclean VA  22102 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trisaccharides A and B
	Trade Name:
	Biosynject	Orphan Designation:
	Treatment of moderate to severe clinical forms of hemolytic disease of the 
	newborn arising from placental transfer of antibodies against blood group 
	Designation 	substances A and B.
	4/12/1987	Sponsor and Address
	Marketing Exclusivity 	Chembiomed, Ltd.
	P.O. Box 8050, Station F
	Edmonton, Alberta
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trisaccharides A and B
	Trade Name:
	Biosynject	Orphan Designation:
	Prevention of ABO medical hemolytic reactions arising from ABO-
	incompatible bone marrow transplantation.
	Designation 
	4/15/1988	Sponsor and Address
	Marketing Exclusivity 	Chembiomed, Ltd.
	P.O. Box 8050
	Edmonton, Alberta
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trisaccharides A and B
	Trade Name:
	Orphan Designation:
	Treatment of moderate to very severe clinical forms of transfusion reactions 
	arising from ABO incompatible transfusions of blood, blood products, and 
	Designation 	blood derivatives.
	8/3/1987	Sponsor and Address
	Marketing Exclusivity 	Chembiomed, Ltd.
	P.O. Box 8050
	Edmonton, Alberta 
	    
	CANADA
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Trisaccharides A and B
	Trade Name:
	Biosynject	Orphan Designation:
	For use in ABO-incompatible solid organ transplantation, including kidney, 
	heart, liver and pancreas.
	Designation 
	4/20/1987	Sponsor and Address
	Marketing Exclusivity 	Chembiomed, Ltd.
	P.O. Box 8050
	Edmonton, Alberta 
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trisodium citrate concentration
	Trade Name:
	Hemocitrate	Orphan Designation:
	For use in leukapheresis procedures.
	Designation 
	6/15/1995	Sponsor and Address
	Marketing Exclusivity 	Hemotec Medical Products, Inc.
	Box 19255
	Johnston RI  02919 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trisodium zinc Diethylenetriaminepentaacetate
	Trade Name:
	Orphan Designation:
	Treatment of patients with known or suspected internal contamination with 
	plutonium, americium, or curium to increase the rate of elimination.
	Designation 
	2/27/2004	Sponsor and Address
	Marketing Exclusivity 	CustomCare Pharmacy
	5710 Hoover Blvd
	Tampa FL  33634 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Troxacitabine
	Trade Name:
	Troxatyl	Orphan Designation:
	Treatment of acute myeloid leukemia
	Designation 
	4/4/2005	Sponsor and Address
	Marketing Exclusivity 	Structural GenomiX, Inc. (SGX)
	10505 Roselle Street
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trypan blue
	Trade Name:
	MembraneBlue	Orphan Designation:
	Selectively staining epiretinal membranes during ophthalmic surgical 
	victrectomy procedures
	Designation 
	8/2/2006	Sponsor and Address
	Marketing Exclusivity 	Dutch Ophthalmic Research Center Int'l BV
	Scheijdelveweg 2
	P.O. Box 43     3214ZG Zuidland
	    
	NETHERLANDS
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Tumor necrosis factor-binding protein 1
	Trade Name:
	Orphan Designation:
	Treatment of symptomatic patients with AIDS including all patients with 
	CD4 counts less than 200 cells per mm3.
	Designation 
	1/6/1993	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tumor necrosis factor-binding protein II
	Trade Name:
	Orphan Designation:
	Treatment of symptomatic patients with the AIDS including all patients with
	 CD4 T-cell counts less than 200 cells per mm3.
	Designation 
	1/6/1993	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tyloxapol
	Trade Name:
	Supervent	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	3/8/1995	Sponsor and Address
	Marketing Exclusivity 	Kennedy & Hoidal, M.D.'s
	University of Utah Health Sciences Center
	50 North Medical Drive, Room 4R240
	Salt Lake City UT  84132-0001
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Type 1 native bovine skin collagen
	Trade Name:
	Orphan Designation:
	Treatment of diffuse systemic sclerosis
	Designation 
	2/1/2008	Sponsor and Address
	Marketing Exclusivity 	arGentis Pharmaceuticals, LLC
	20 South Dudley Street
	Memphis TN  38139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	tyrosine kinase inhibitor
	Trade Name:
	Orphan Designation:
	Treatment of mastocytosis
	Designation 
	9/14/2005	Sponsor and Address
	Marketing Exclusivity 	AB Science
	3, avenue GeorgeV
	75008 Paris
	    
	FRANCE
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Ubiquinol
	Trade Name:
	Ubi-Q-Nol, Li-Q-Nol	Orphan Designation:
	Treatment of Huntington's Disease
	Designation 
	4/12/2004	Sponsor and Address
	Marketing Exclusivity 	Gel-Tec, Division of Tishcon Corp
	30 New York Avenue
	P. O. Box 331
	Westbury NY  11590 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ubiquinol, coenzyme Q10, ubiquinone
	Trade Name:
	UBI-Q-NOL	Orphan Designation:
	Treatment of pediatric congestive heart failure
	Designation 
	4/12/2004	Sponsor and Address
	Marketing Exclusivity 	Gel-Tec, Division of TISHCON Corporation
	30 New York Avenue
	P.O. Box 331
	Westbury NY  11590 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ubiquinone
	Trade Name:
	Ubi-Q-Gel	Orphan Designation:
	Treatment of mitochondrial cytopathies.   
	Designation 
	12/14/1999	Sponsor and Address
	Marketing Exclusivity 	Gel-Tec, Division of Tishcon Corp.
	30 New York Ave.
	PO Box 331
	Westbury NY  11590 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Unconjugated Chimeric (human-murine) G250 IgG 
	monoclonal antibody
	Trade Name:
	Orphan Designation:
	Treatment of renal cell carcinoma.  
	Designation 
	3/22/2001	Sponsor and Address
	Marketing Exclusivity 	Wilex Biotechnology GmbH
	Grillparzerstrasse 10B
	81675 Munich
	    
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Urea for intravitreal injection
	Trade Name:
	Neurosolve	Orphan Designation:
	Treatment of retinitis pigmentosa
	Designation 
	12/14/2005	Sponsor and Address
	Marketing Exclusivity 	Vitreo Retinal Techologies, Inc
	2 Venture Plaza
	Irvine CA  92618 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Uridine 5'-triphosphate
	Trade Name:
	Orphan Designation:
	To facilitate the removal of lung secretions in the treatment of patients with
	 primary ciliary dyskinesia.
	Designation 
	6/26/1996	Sponsor and Address
	Marketing Exclusivity 	Inspire Pharmaceuticals, Inc.
	4222 Emperor Boulevard, Suite 470
	Durham NC  27703 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Uridine 5'-triphosphate
	Trade Name:
	Orphan Designation:
	Treatment of cystic fibrosis.
	Designation 
	12/4/1995	Sponsor and Address
	Marketing Exclusivity 	Inspire Pharmaceuticals, Inc.
	4222 Emperor Boulevard, Suite 470
	Durham NC  27703 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Urofollitropin
	Trade Name:
	Metrodin	Orphan Designation:
	For induction of ovulation in patients with polycystic ovarian disease who 
	have an elevated LH/FSH ratio and who have failed to respond to 
	Designation 	adequate clomiphene citrate therapy.
	11/25/1987	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	9/18/1986	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Urofollitropin
	Trade Name:
	Fertinex	Orphan Designation:
	For the initiation and re-initiation of spermatogenesis in adult males with 
	reproductive failure due to hypothalamic or pituitary dysfunction, 
	Designation 	hypogonadotropic hypogonadism.
	12/5/1997	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	One Technology Place
	Rockland  MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Urogastrone
	Trade Name:
	Orphan Designation:
	For acceleration of corneal epithelial regeneration and healing of stromal 
	incisions from corneal transplant surgery.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	Chiron Vision
	500 Iolab Drive
	Claremont CA  91711 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	ursodiol 
	Trade Name:
	Ursofalk Suspension	Orphan Designation:
	Treatment of cystic fibrosis liver disease,
	Designation 
	10/23/2007	Sponsor and Address
	Marketing Exclusivity 	Asklepion Pharmaceuticals, LLC
	5200 Maryland Way
	Brentwood TN  37027 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ursodiol
	Trade Name:
	Actigall	Orphan Designation:
	Management of the clinical signs and symptoms associated with primary 
	biliary cirrhosis.
	Designation 
	2/19/1991	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ursodiol
	Trade Name:
	URSO	Orphan Designation:
	Treatment of patients with primary biliary cirrhosis.
	Designation 
	6/20/1991	Sponsor and Address
	Marketing Exclusivity 	Axcan Pharma Inc.
	12/10/1997	597 Laurier Blvd
	Mount St. Hilaire Quebec  H7L 4S3
	    
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Vaccinia Immune Globulin (Human) Intravenous	treatment and/or modification of the following conditions, which are 
	complications resulting from smallpox vaccination: Eczema vaccinatum 
	Progressive vaccinia Severe generalized vaccinia Vaccinia infections in 
	Trade Name:	individuals who have skin conditions such as burns, impetigo, varicella-
	zoster, or poison ivy; or in individuals who have eczematous skin lesions 
	because of either the activity or extensiveness of such lesions Aberrant 
	infections induced by vaccinia virus that include its accidental implantation
	 in eyes (except in cases of isolated keratitis), mouth, or other areas where 
	CNJ-016	Orphan Designation:
	Treatment of complications of vaccinia vaccination
	Designation 
	6/18/2004	Sponsor and Address
	Marketing Exclusivity 	Cangene Corporation
	1/1/9999	104 Chancellor Matheson Road
	Winnipeg, ManitobaR3T 5Y3    
	 
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Vaccinia Immune Globulin (Human) Intravenous	Treatment and modification of aberrant infections induced by vaccinia virus
	 that include its accidental implantation in eyes (except in cases of isolated 
	keratitis), mouth, or other areas where vaccinia infection would constitute a 
	Trade Name:	special hazard; eczema vaccinatum; progressive vaccinia; severe 
	generalized vaccinia, and vaccinia infections in individuals who have skin 
	conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in 
	individuals who have eczematous skin lesions because of either the activity 
	Orphan Designation:
	Treatment of severe complications from the smallpox vaccine
	Designation 
	6/18/2004	Sponsor and Address
	Marketing Exclusivity 	DynPort Vaccine Company LLC
	2/18/2005	64 Thomas Johnson Drive
	Frederick MD  21702 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Valine, isoleucine and leucine
	Trade Name:
	VIL	Orphan Designation:
	Treatment of hyperphenylalaninemia.
	Designation 
	1/5/1996	Sponsor and Address
	Marketing Exclusivity 	Leas Research Products
	78 Fallon Drive
	North Haven CT  06473 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	valine-valine-ganciclovir
	Trade Name:
	Orphan Designation:
	Treatment of primary keratoconjunctivitis and recurrent epithelial keratitis 
	due to HSV1 and HSV2.
	Designation 
	5/21/2007	Sponsor and Address
	Marketing Exclusivity 	Verenta Pharmaceuticals, Inc.
	10901 Granada Lane
	Suite 101
	Leawood KS  66211 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Valproate
	Trade Name:
	Orphan Designation:
	Treatment of fragile X syndrome
	Designation 
	5/5/2008	Sponsor and Address
	Marketing Exclusivity 	Neuropharm Ltd,
	Fetcham Park House
	Surrey KT22 9HD
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Valproic acid, sodium
	Trade Name:
	PEAC	Orphan Designation:
	Treatment of familial adenomatous polyposis
	Designation 
	6/24/2005	Sponsor and Address
	Marketing Exclusivity 	Topo Target Germany AG
	Paul-Ehrlich Str. 42-44
	D-60596 Frankfurt am Main
	    
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Valrubicin	For intravesical therapy of BCG-refractory carcinoma in situ of the urinary 
	bladder in patients for whom immediate cystectomy would be associated 
	with unacceptable morbidity or mortality.
	Trade Name:
	Valstar	Orphan Designation:
	Treatment of carcinoma in situ of the urinary bladder.
	Designation 
	5/23/1994	Sponsor and Address
	Marketing Exclusivity 	Anthra Pharmaceuticals, Inc.
	9/25/1998	103 Carnegie Center, Suite 102
	Princeton NJ  08540 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Vandetanib
	Trade Name:
	Zactima	Orphan Designation:
	Treatment of patients with follicular thyroid carcinoma, medullary thyroid 
	carcinoma, anaplastic thyroid carcinoma, and locally advanced and 
	Designation 	metastatic papillary thyroid carcinoma
	10/21/2005	Sponsor and Address
	Marketing Exclusivity 	AstraZeneca Pharmaceutical LP
	1800 Concord Pike
	Wilmington DE  19830-8355
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Vapreotide
	Trade Name:
	Sanvar	Orphan Designation:
	Treatment of symptomatic carcinoid tumors
	Designation 
	4/6/2004	Sponsor and Address
	Marketing Exclusivity 	H3 Pharma, Inc.
	666 Sherbrooke Street West    Suite 1400
	Montreal, Quebec,
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	vapreotide
	Trade Name:
	Sanvar	Orphan Designation:
	Treatment of esophageal variceal hemorrhage patients with portal 
	hypertension.
	Designation 
	1/10/2000	Sponsor and Address
	Marketing Exclusivity 	Debiovision, Inc.
	666 Sherbrooke Street West
	Suite 1400
	Montreal, Quebec H3A 1E7    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	vapreotide
	Trade Name:
	Octastatin	Orphan Designation:
	Treatment of gastrointestinal and pancreatic fistulas. 
	Designation 
	1/10/2000	Sponsor and Address
	Marketing Exclusivity 	Debiopharm S.A.
	17 rue des Terreaux
	CH-1000 Lausanne 9
	    
	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	vapreotide
	Trade Name:
	Octastatin	Orphan Designation:
	Prevention of early postoperative complications following pancreatic 
	resection.  
	Designation 
	3/6/2000	Sponsor and Address
	Marketing Exclusivity 	Debiopharm S.A.
	17 rue des Terreaux
	CH-1000 Lausanne 9
	    
	SWITZERLAND
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	vapreotide 
	Trade Name:
	Sanvar	Orphan Designation:
	For the treatment of acromegaly
	Designation 
	11/4/2003	Sponsor and Address
	Marketing Exclusivity 	H3 Pharma, Inc.
	666 Sherbrooke Street West, Suite 1400
	Montreal, Quebec
	    
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	varespladib sodium
	Trade Name:
	Orphan Designation:
	Prevention of acute chest syndrome in at-risk patients with sickle cell 
	disease
	Designation 
	11/19/2007	Sponsor and Address
	Marketing Exclusivity 	Anthera Pharmaceuticals, Inc.
	1900 S. Norfolk St.
	Suite 260
	San Mateo CA  94403 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Varicella Zoster Immune Globulin (Human)
	Trade Name:
	VariZIG	Orphan Designation:
	Passive immunization for the treatment of exposed, susceptible individuals 
	who are at risk of complications from varicella
	Designation 
	11/7/2006	Sponsor and Address
	Marketing Exclusivity 	Cangene Corporation
	155 Innovation Drive
	R3T 5Y3
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Vasoactive intestinal peptide
	Trade Name:
	Orphan Designation:
	Treatment of Acute Respiratory Distress Syndrome.
	Designation 
	3/9/2001	Sponsor and Address
	Marketing Exclusivity 	mondoBIOTECH
	Europark
	Austrasse 79
	    
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Vasoactive intestinal polypeptide
	Trade Name:
	Orphan Designation:
	Treatment of acute esophageal food impaction.
	Designation 
	6/23/1993	Sponsor and Address
	Marketing Exclusivity 	Research Triangle Pharmaceuticals
	200 Westpark Corporate Center
	4364 South Alston Avenue
	Durham NC  27713-2280
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Vibriolysin
	Trade Name:
	Vibrilase	Orphan Designation:
	Debridement of severe, deep dermal burns in hospitalized patients 
	Designation 
	6/16/2006	Sponsor and Address
	Marketing Exclusivity 	BioMarin Pharmaceutical Inc.
	105 Digital Drive
	Novato CA  94949 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	vigabatrin
	Trade Name:
	Sabril	Orphan Designation:
	Treatment of infantile spasms.
	Designation 
	6/12/2000	Sponsor and Address
	Marketing Exclusivity 	Ovation Pharmaceuticals, Inc.
	Four Parkway North
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Viloxazine HCl
	Trade Name:
	Catatrol	Orphan Designation:
	Treatment of narcolepsy.
	Designation 
	6/11/1984	Sponsor and Address
	Marketing Exclusivity 	Stuart Pharmaceuticals
	Division of ICI Americas
	Wilmington DE  19897 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Viloxazine HCl
	Trade Name:
	Catatrol	Orphan Designation:
	Treatment of cataplexy.
	Designation 
	6/11/1984	Sponsor and Address
	Marketing Exclusivity 	Stuart Pharmaceuticals
	Division of ICI Americas
	Wilmington DE  19897 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	vincristine sulfate liposome injection
	Trade Name:
	Marqibo	Orphan Designation:
	Treatment of acute lymphoblastic leukemia.
	Designation 
	1/8/2007	Sponsor and Address
	Marketing Exclusivity 	Hana Biosciences, Inc.
	7000 Shoreline Court
	South San Francisco CA  94080 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Virulizin
	Trade Name:
	Virulizin	Orphan Designation:
	Treatment of pancreatic cancer.
	Designation 
	2/1/2001	Sponsor and Address
	Marketing Exclusivity 	Lorus Therapeutics Inc.
	7100 Woodbine Avenue, Suite 215
	Markham, ON L3R 5J2
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	viscous budesonide
	Trade Name:
	Orphan Designation:
	Treatment for pediatric eosinophilic esophagitis.
	Designation 
	12/20/2006	Sponsor and Address
	Marketing Exclusivity 	University of California San Diego Medical Center
	Hillcrest
	San Diego CA  92103-8450
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	vorinostat
	Trade Name:
	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	6/12/2003	Sponsor and Address
	Marketing Exclusivity 	Merck Research Laboratories
	Merck & Co., Inc.
	P. O. Box 2000, RY 32-605
	Rahway NJ  07065-0900
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	vorinostat	Treatment of cutaneous manifestations in patients with cutaneous T-cell 
	lymphoma (CTCL) who have progressive, persistant or recurrent disease on 
	or following two systemic therapies.
	Trade Name:
	Zolinza	Orphan Designation:
	Treatment of T-cell non-Hodgkin's lymphoma
	Designation 
	3/16/2004	Sponsor and Address
	Marketing Exclusivity 	Merck & Co., Inc.
	10/6/2006	P. O. Box 2000, RY 32-605
	Rahway NJ  07065-0900
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	vorinostat
	Trade Name:
	Orphan Designation:
	Treatment of mesothelioma
	Designation 
	3/17/2004	Sponsor and Address
	Marketing Exclusivity 	Merck & Co., Inc.
	P. O. Box 2000, RY 32-605
	Rahway NJ  07065-0900
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Xenogeneic hepatocytes
	Trade Name:
	HepatAssist Liver Assist System	Orphan Designation:
	Treatment of severe liver failure.
	Designation 
	11/27/1998	Sponsor and Address
	Marketing Exclusivity 	Circe Biomedical, Inc.
	99 Hayden Ave.
	Lexington MA  02421-7995
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Yttrium (90Y) antiferritin polyclonal antibodies
	Trade Name:
	Ferritarg P	Orphan Designation:
	Treatment of Hodgkin's disease.
	Designation 
	9/18/2006	Sponsor and Address
	Marketing Exclusivity 	MAT Biopharma
	4 rue Pierre Fontaine

	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Yttrium-90 radiolabeled humanized monoclonal 
	anti-carcinoembroyonic antigen IgG antibody
	Trade Name:
	Cea-Cide	Orphan Designation:
	Treatment of ovarian carcinoma.  
	Designation 
	8/3/1999	Sponsor and Address
	Marketing Exclusivity 	Immunomedics, Inc.
	300 American Rd.
	Morris Plains NJ  07950 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Zalcitabine	Combination therapy with zidovudine is indicated for the treatment of adult
	 patients with advanced HIV infection (CD4 count < 300) who have 
	demonstrated malignant clinical or immunologic deterioration.
	Trade Name:
	Hivid	Orphan Designation:
	Treatment of AIDS.
	Designation 
	6/28/1988	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	6/19/1992	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Zalcitabine
	Trade Name:
	Orphan Designation:
	Treatment of AIDS.
	Designation 
	12/9/1986	Sponsor and Address
	Marketing Exclusivity 	National Cancer Institute, DCT
	NIH, Executive Plaza North, Room 7-18
	Bethesda MD  20892 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Zidovudine
	Trade Name:
	Retrovir	Orphan Designation:
	Treatment of AIDS.
	Designation 
	7/17/1985	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	3/19/1987	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Zidovudine
	Trade Name:
	Retrovir	Orphan Designation:
	Treatment of AIDS related complex.
	Designation 
	7/17/1985	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	3/19/1987	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Zinc acetate	For maintenance treatment of patients with Wilson's disease who have been
	 initially treated with a chelating agent.
	Trade Name:
	Galzin	Orphan Designation:
	Treatment of Wilson's disease.
	Designation 
	11/6/1985	Sponsor and Address
	Marketing Exclusivity 	Lemmon Company
	1/28/1997	1510 Delp Drive
	Kulpsville PA  19443 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Zoledronate	Treatment of hypercalcemia of malignancy.
	Trade Name:
	Zometa, Zabel	Orphan Designation:
	Treatment of tumor induced hypercalcemia.  
	Designation 
	8/18/2000	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corp.
	8/20/2001	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Zosuquidar trihydrochloride 
	Trade Name:
	Orphan Designation:
	Treatment of acute myeloid leukemia
	Designation 
	12/15/2005	Sponsor and Address
	Marketing Exclusivity 	Kanisa Pharmaceuticals, Inc.
	12264 El Camino Real
	San Diego CA  02130 
	 
	***************************************************************************************