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Orphan Drugs: FDA PDUFA Dates February – March 2014

February 17, 2014





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

FDA PDUFA Dates February – March 2014

Generic       Name Trade          Name Sponsor Indication 2014          PDUFA  Date
Droxidopa   * Northera Chelsea   Therapeutics Symptomatic     Neurogenic Orthostatic Hypotension For Patients With Primary Autonomic     Failure 02/18
Metreleptin   ** Bristol-Myers   Squibb/AstraZeneca Lipodystrophy 02/27
Miltefosine   *** Impavido Paladin   Labs Leishmaniasis 03/19
Ivacaftor **** Kalydeco Vertex   Pharmaceuticals Cystic   Fibrosis, ages 6 & older who have non-G551D gating mutations 03/27

* Resubmitted NDA   ** Priority Review   *** NDA    **** sNDA, 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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