Hyperion Therapeutics Notified That FDA Will Not Meet the PDUFA Action Date for Ravicti
1/16/2013 9:13:19 AM
SOUTH SAN FRANCISCO, Calif., Jan. 16, 2013 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (Nasdaq:HPTX) said that the U.S. Food and Drug Administration (FDA) has advised the Company not to expect a final action by the Prescription Drug User Fee Act (PDUFA) action date of January 23, 2013. The agency explained it is continuing to work on label and post-marketing requirements in connection with Hyperion's New Drug Application (NDA) for Ravicti™ (glycerol phenylbutyrate) for the treatment of Urea Cycle Disorders (UCD).
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