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New Drug Applications Archive - May 2015

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May 4, 2015

AcelRx Pharmaceuticals Provides Zalviso Regulatory Update

May 12, 2015

FDA Advisory Panel Voted 12 to 1 to Recommend Approval of Orkambi (lumacaftor/ivacaftor) for Cystic Fibrosis F508del Mutation

May 21, 2015

Tris Pharma Announces the FDA Acceptance of NDA for Dyanavel XR

May 26, 2015

ZS Pharma Submits NDA for ZS-9 for the Treatment of Hyperkalemia

May 27, 2015

FDA Accepts BPL’s Amended BLA Submission for Coagadex (Coagulation Factor X, Human)

May 28, 2015

Merck Submits NDA for Grazoprevir/Elbasvir for Chronic Hepatitis C Genotypes 1, 4, and 6 Infection

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