New Drug Applications Archive - May 2016
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May 1, 2016
May 4, 2016
May 5, 2016
- Clovis Oncology Terminates Enrollment in all Ongoing Sponsored Clinical Studies of Rociletinib
- Statement Regarding FDA Advisory Committee Meeting on KemPharm’s Abuse-Deterrent Product Candidate Apadaz
May 20, 2016
May 23, 2016
May 24, 2016
- IDegLira Receives Positive 16-0 Vote in Favour of Approval from FDA Advisory Committee
- Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%
May 25, 2016
- FDA Advisory Committee Recommends Approval of Sanofi Treatment for Adults With Type 2 Diabetes
- Sarepta Therapeutics Announces FDA Will Not Complete the Review of the Eteplirsen NDA By The PDUFA Date
May 26, 2016
May 27, 2016
May 31, 2016
- Lexicon Announces FDA Priority Review of NDA for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
- Radius Announces FDA Acceptance for Filing of NDA for Abaloparatide-SC for the Treatment of Postmenopausal Women with Osteoporosis
- Teva Receives Complete Response Letter for NDA for SD-809 for the Treatment of Chorea Associated with Huntington Disease
- FDA Grants Soligenix “Fast Track” Designation for SGX943 for the Treatment of Melioidosis
