Strange, as this was their PR this morning:
HPTX - (Hyperion Notified That FDA Will Not Meet the PDUFA Action Date for Ravicti(TM))
SOUTH SAN FRANCISCO, Calif., Jan 16, 2013 (GLOBE NEWSWIRE via COMTEX) --
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(TM) (glycerol phenylbutyrate) for the treatment of Urea Cycle Disorders
(UCD).
About Ravicti(TM) (glycerol phenylbutyrate)
Ravicti, an investigational drug, is a pre-pro-drug of phenylacetic acid, the
active moiety of BUPHENYL, the only branded therapy currently FDA-approved as
adjunctive therapy for the chronic management of patients with the most
prevalent urea cycle disorders. Ravicti holds orphan product designations in the
US and Europe for the maintenance treatment of patients with urea cycle
disorders and in the US for the intermittent or chronic treatment of patients
with cirrhosis and any grade of hepatic encephalopathy.
Fear leads to anger. Anger leads to hate. Hate leads to suffering.
AI
