List of Orphan Products Receiving Designation during the Year 2008
	Total Number of Active Designations  	61	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:
	(+/- 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:
	(+/-)-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:
	(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:
	(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:
	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:
	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:
	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:
	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-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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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 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 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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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 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:
	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:
	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:
	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:
	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:
	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:
	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:
	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:
	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
	***************************************************************************************