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Upcoming 2012 FDA PDUFA Dates For Orphan Drugs

November 25, 2012
Generic Name Trade Name  Sponsor Indication PDUFA Date
Cabozantinib   Exelixis  Medullary Thyroid Cancer (MTC) 11/29/12
Raxibacumab   GSK Anthrax 12/15/12
Lomitapide   Aegerion Pharmaceuticals Homozygous Familial Hypercholesterolemia (HoFH) On or about 12/29/12
Teduglutide Gattex NPS Pharmaceuticals Short Bowel Syndrome (SBS) 12/30/12

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

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

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