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FDA Will Not Meet PDUFA Date for Hyperion's Ravicti

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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).

Posted-In: News FDA


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