New Drug Applications Archive - March 2016
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March 2, 2016
March 3, 2016
March 15, 2016
March 17, 2016
- FDA Rules Favorably On Efficacy Of Travivo (Gepirone ER) For Treatment Of Major Depressive Disorder
- Elite Announces U.S. FDA Priority Review Designation for SequestOx NDA
March 22, 2016
March 29, 2016
- Newron Receives Complete Response Letter from US FDA for Xadago (safinamide)
- FDA Advisory Committee Votes 12 to 2 That Benefits of Nuplazid (Pimavanserin) for the Treatment of Psychosis Associated with Parkinson’s Disease Outweigh the Risks
- Pain Therapeutics Resubmits Remoxy New Drug Application to the U.S. Food and Drug Administration
March 30, 2016
- Lexicon Submits New Drug Application to FDA for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
- OPKO Receives Complete Response Letter from FDA for Rayaldee New Drug Application
- Shionogi Submits New Drug Applications in Japan and the U.S. for Naldemedine for the Treatment of Opioid-Induced Constipation
- Radius Health Submits NDA to the U.S. FDA for Abaloparatide-SC for the Treatment of Postmenopausal Women with Osteoporosis
