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Biocryst Pharmaceuticals (BCRX) Announces Peramivir NDA Acceptance By The FDA



2/25/2014 9:00:36 AM

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RESEARCH TRIANGLE PARK, N.C., Feb. 25, 2014 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravenous (i.v.) peramivir that was submitted to the FDA in December 2013. The FDA assigned the NDA a standard review time, resulting in a PDUFA (Prescription Drug User Fee Act) action date of December 23, 2014. The FDA has informed BioCryst that at this time, it does not plan to hold an Advisory Committee review of the NDA.

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