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KYTHERA Biopharmaceuticals announces FDA acceptance of ATX-101 New Drug Application

Thursday, 10 Jul 2014 04:32pm EDT 

KYTHERA Biopharmaceuticals Inc:Announces that its New Drug Application (NDA) for ATX-101 (deoxycholic acid), has been accepted for filing by the U.S. Food and Drug Administration (FDA).Acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review.NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015. 

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