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ARTICLE | Company News

FDA dings NDA for Avanir migraine therapy

November 8, 2014 3:04 AM UTC

Avanir Pharmaceuticals Inc. (NASDAQ:AVNR) said FDA is unlikely to approve AVP-825 by the migraine therapy's Nov. 25 PDUFA date. The company received a discipline review letter in which the agency questioned study data related to human/device interactions in the NDA, and asked Avanir to "optimize the product-user interface" and conduct additional testing of AVP-825. FDA discipline review letters note any deficiencies in specific sections of applications. ...