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Orphan Drugs: FDA PDUFA Dates January – February 2014

January 9, 2014





Investors and traders will be watching several orphan drug FDA PDUFA dates in January and February 2014.

FDA PDUFA Dates January – February 2014

Generic    Name Trade       Name Sponsor Indication 2014       PDUFA  Date
Tasimelteon Hetlioz Vanda    Pharmaceuticals Non-24 Hour Sleep/Wake   Disorder in Blind Individuals Without Light Perception 01/31
Droxidopa * Northera Chelsea   Therapeutics Symptomatic   Neurogenic Orthostatic Hypotension For Patients With Primary Autonomic   Failure 02/14
Metreleptin Bristol-Myers   Squibb Lipodystrophy 02/27
Elosulfase Alfa ** Vimizim BioMarin   Pharmaceutical Mucopolysaccharidosis   Type IV A (Morquio A Syndrome) 02/28
Ibrutinib Imbruvica Pharmacyclics Chronic/Small-Cell  Lymphocytic Leukemia 2/28


* Resubmission

** Priority Review

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 notify at if any updates or corrections are available.

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

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

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