New Drug Applications Archive - September 2015
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September 1, 2015
September 2, 2015
September 3, 2015
- FDA Grants Fast Track Designation for Iclaprim
- Acadia Pharmaceuticals Submits NDA for Nuplazid for the Treatment of Parkinson’s Disease Psychosis
September 4, 2015
September 6, 2015
September 8, 2015
September 9, 2015
September 10, 2015
- Wellstat Therapeutics’ NDA for Uridine Triacetate as Antidote to Overexposure to Chemotherapy Drug 5-Fluorouracil (5-FU) Accepted for Review by FDA
- U.S. FDA Accepts First Digital Medicine New Drug Application for Otsuka and Proteus Digital Health
September 11, 2015
- Collegium Announces FDA Advisory Committees Unanimously Recommend Approval of Xtampza ER, an Abuse-Deterrent Analgesic for Chronic Pain
- FDA Accepts Filing of Ameluz and BFRhodoLED New Drug Application
September 14, 2015
September 15, 2015
September 16, 2015
September 17, 2015
September 22, 2015
- Bausch+Lomb and Nicox Announce FDA Acceptance of NDA for Novel Glaucoma Candidate Vesneo (latanoprostene bunod)
- Evofem, Inc. Announces FDA Acceptance of New Drug Application for Amphora as a Contraceptive
- Kythera Biopharmaceuticals Submits Investigational New Drug Application for KYTH-105 to Treat Androgenetic Alopecia
September 23, 2015
September 28, 2015
- Titan Pharmaceuticals Announces FDA's Acceptance of Resubmission of NDA for Probuphine
- Ocular Therapeutix Submits NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain
