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Orphan Drugs: 2014 FDA PDUFA Dates

August 15, 2014

Biotechnology stock movements are affected at various phases of the US FDA’s drug approval process. Big stock moves, either up or down, are associated with several catalysts:

•   Release of Trial Data

•   Briefing documents prior to Advisory Committee meetings (AdComs)

•   AdComs themselves

•   Prescription Drug User Fee Act (PDUFA) dates.

Investors and traders will be watching several upcoming FDA PDUFA dates for orphan drugs for the remainder of 2014.

2014 FDA PDUFA Dates

Generic Name Trade Name Sponsor Indication 2014 PDUFA Date
(Recombinant Human Parathyroid Hormone 1-84, (rhPTH[1-84])) * Natpara NPS Pharmaceuticals Hypoparathyroidism 10/24
Eltrombopag ** Promacta GlaxoSmithKline Severe Aplastic Anemia (SAA) 10/30
Macimorelin Acetate   *** Aeterna Zentaris Adult Growth Hormone Deficiency (AGHD) 11/05
Pirfenidone **** Esbriet InterMune Idiopathic Pulmonary Fibrosis (IPF) 11/23
Ruxolitinib ***** Jakafi Incyte Corporation Polycythemia Vera (PV) 12/05


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

* Biologics License Application (BLA)

** sNDA/Priority Review/Breakthrough Therapy Designation (BTD)

*** NDA

**** Resubmitted Class 2 NDA/Breakthrough Designation (BTD)

***** sNDA

Please Note: “Azt” by John Crawford (Photographer) [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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