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BioDelivery Sciences International Inc Announces FDA Acceptance of BUNAVAIL NDA for Filing


Wednesday, 9 Oct 2013 07:00am EDT 

BioDelivery Sciences International Inc announced that its New Drug Application (NDA) for BUNAVAIL (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence has been accepted for filing by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review. Based on timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the BUNAVAIL NDA is expected to be completed by early June 2014.