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Orphan Drugs: April – September 2013 PDUFA Dates

March 27, 2013
Generic Name Trade Name Sponsor Indication PDUFA Date
Cysteamine Bitartrate Procysbi Raptor Pharmaceutical Cystinosis 4/30/13
Dabrafenib &   Trametinib GlaxoSmithKline Melanoma 6/3/13
Lenalidomide Revlimid Celgene Corporation Mantle Cell Lymphoma 6/5/13
Collagenase   Clostridium Histolyticum Xiaflex Auxilium Pharmaceuticals Peyronie’s Disease 9/6/13

Please notify at if any updates or corrections are available.

Please note the links for the following 2 chart columns above :

1) “Generic Name” Column Link = Is a source for the FDA PDUFA Date

2) “Indication” Column Link = Is the FDA Orphan Drug Product Designation Database Link.

Please Note #2: FDA Official Logo from FDA website.

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