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January – June 2013 FDA PDUFA Dates For Orphan Drugs (01.24.13 Update)

January 24, 2013
Generic Name Trade Name Sponsor Indication PDUFA Date
Mipomersen   Sodium Kynamro Genzyme/Isis Pharmaceuticals Homozygous Familial Hypercholesterolemia (HoFH) 1/29/13
Ampligen Hemispherx BioPharma Chronic Fatigue Syndrome (CFS) 2/02/13
Pomalidomide Pomalyst Celgene Corporation Multiple Myeloma 2/10/13
Regorafenib Stivarga Bayer GastroIntestinal Stromal Tumors (GIST) 2/28/13
Glycerol    Phenylbutyrate Ravicti Hyperion Therapeutics Urea    Cycle Disorder (UCD) 4/23/13
Cysteamine   Bitartrate Procysbi Raptor Pharmaceutical Cystinosis 4/30/13
Dabrafenib & Trametinib GlaxoSmithKline Melanoma 6/3/13

Please notify at if any updates 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

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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