List of Orphan Designated Approved Products YTD 2008
	Total Number of Active Designations  	13	Effective:	5/16/2008
	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
	 
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	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
	 
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	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 
	 
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	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 
	 
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	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 
	 
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	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 
	 
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	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 
	 
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	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 
	 
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	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
	 
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	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 
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	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 
	 
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	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 
	 
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	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
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