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New Drug Applications Archive - April 2016

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April 10, 2016

FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva (obeticholic acid) for the Treatment of Primary Biliary Cirrhosis

April 12, 2016

Clovis Oncology Provides Update on FDA Oncologic Drugs Advisory Committee Meeting to Review Rociletinib
FDA Accepts Remoxy NDA for Review
Merck Announces FDA Acceptance of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet

April 15, 2016

FDA Issues Complete Response Letter for Mycapssa New Drug Application

April 18, 2016

Heron Therapeutics Provides Update on FDA Review of Sustol NDA

April 19, 2016

April 22, 2016

FDA Accepts Lundbeck Resubmission of New Drug Application for Carnexiv (carbamazepine)

April 25, 2016

Sarepta Issues Statement on Advisory Committee Outcome for Use of Eteplirsen in the Treatment of Duchenne Muscular Dystrophy

April 26, 2016

April 27, 2016

FDA Accepts Resubmission of New Drug Application for Rayaldee

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