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Orphan Drugs: FDA Advisory Committee Meetings (November – December 2013)

October 23, 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.

The following chart identifies upcoming FDA Advisory Committee Meetings for the remainder of 2013.

FDA Advisory Committee Meetings (November – December 2013)

Generic       Name Trade       Name Sponsor Indication 2013 AdCom    Date
Tasimelteon Hetlioz Vanda   Pharmaceuticals Non-24   Hour Sleep-Wake Disorder In Blind Individuals Without Light Perception 11/14
Elosulfase   Alfa Vimizim BioMarin   Pharmaceutical Mucopolysaccharidosis   Type IVA (Morquio A Syndrome) 11/19
Metreleptin Amylin   Pharmaceuticals Metabolic   Disorders Associated With Lipodystrophy 12/11

Please note the links for the following 2 chart columns above :

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

2) “2013 AdCom Date” = Is the FDA Advisory Committee Meeting Information.

Please Note: FDA Official Logo from FDA website.

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


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