Hyperion
Therapeutics, Inc. 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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