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Orphan Drugs: FDA PDUFA Dates August – December 2013 (07.23.13)

July 23, 2013

Investors and traders will be watching several orphan drug FDA PDUFA dates for August through December 2013.

FDA PDUFA Dates August – December 2013

Generic    Name Trade    Name Sponsor Indication 2013    PDUFA  Date
Collagenase     Clostridium Histolyticum Xiaflex Auxilium   Pharmaceuticals Peyronie’s   Disease 09/06
Melphalan   Hydrochloride Melblez   Kit Delcath   Systems Ocular Melanoma   Metastatic To Liver 09/13
Macitentan Opsumit Actelion   Pharmaceuticals Pulmonary Arterial   Hypertension (PAH) 10/19
Miltefosine   * Impavido Paladin   Therapeutics Leishmaniasis 12/19
Obinutuzumab   * Genentech Chronic   Lymphocytic Leukemia (CLL) 12/20

* Priority Review

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: FDA Official Logo from FDA website.

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

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