News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

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 Ravictiâ„¢ (glycerol phenylbutyrate) for the treatment of Urea Cycle Disorders (UCD).

Read at GlobeNewswire


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES