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Upcoming January – March 2013 FDA PDUFA Dates For Orphan Drugs (December 26, 2012 Update)

December 7, 2012
Generic Name Trade Name Sponsor Indication PDUFA Date
Glycerol Phenylbutyrate Ravicti Hyperion Therapeutics Urea Cycle Disorder (UCD) 1/23/13
Mipomersen   Sodium Kynamro Genzyme/Isis Pharmaceuticals Homozygous Familial Hypercholesterolemia (HoFH) 1/29/13
Ampligen Hemispherx BioPharma Chronic Fatigue Syndrome (CFS) 2/02/13
Pomalidomide Celgene Corporation Relapsed refractory multiple myeloma 2/10/13
Regorafenib Stivarga Bayer GastroIntestinal Stromal Tumors (GIST) 2/28/13
Ponatinib Ariad Pharmaceuticals Chronic   Myeloid Leukemia & Acute Lymphoblastic Leukemia 3/27/13
Cysteamine   Bitartrate Procysbi Raptor Pharmaceutical Nephropathic   Cystinosis 4/30/13

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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