New Drug Applications Archive - December 2015
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December 1, 2015
December 2, 2015
December 6, 2015
December 7, 2015
December 9, 2015
December 10, 2015
December 15, 2015
- Egalet Submits NDA for Arymo ER (Morphine Sulfate) Extended-Release Tablets
- Clovis Oncology Receives Notification of PDUFA Extension for Rociletinib
December 17, 2015
- Catalyst Pharmaceuticals Completes NDA Submission to FDA for Firdapse for the Treatment of Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenic Syndromes
- FDA Extends PDUFA Date for Obeticholic Acid for the Treatment of PBC
December 18, 2015
- BioMarin Announces That FDA Has Advised it Will Not Take Action on the Kyndrisa (drisapersen) NDA by the PDUFA Date
- Portola Pharmaceuticals Completes BLA Submission to U.S. Food and Drug Administration for Andexanet Alfa
