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Orphan Drugs: FDA PDUFA Dates June – October 2013 (05.15.13)

May 15, 2013

Investors and traders will be watching several orphan drug FDA PDUFA dates for June through October 2013.  Biotechnology stock movements are affected at various phases of the FDA’s drug approval process. Big stock moves, either up or down, are associated with several catalysts :

– Releases of trial data

– Briefing documents prior to Advisory Committee meetings (AdComs)

– AdComs themselves

– Prescription Drug User Fee Act (PDUFA) dates.

Biotechnology share prices usually rise as the FDA PDUFA approval decision date nears. It is at this time that investors and traders place their bets on approval and the resulting benefits to the company. As the PDUFA date draws close, trading activity increases.

FDA PDUFA Dates June – October 2013

Generic    Name Trade    Name Sponsor Indication 2013 PDUFA     Date
Dabrafenib GlaxoSmithKline Melanoma 06/03
Lenalidomide Revlimid Celgene   Corporation Mantle   Cell Lymphoma 06/05
Trametinib GlaxoSmithKline Melanoma 09/03
Collagenase   Clostridium Histolyticum Xiaflex Auxilium   Pharmaceuticals Peyronie’s   Disease 09/06
Macitentan Opsumit Actelion   Pharmaceuticals Pulmonary Arterial Hypertension (PAH) 10/19

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.

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

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