Market Overview

FDA Will Not Meet PDUFA Date for Hyperion's Ravicti

Share:
Related
US Stock Futures Mixed Ahead Of Housing-Market Report
Events for the Week of Nov. 17-21, 2014
Hyperion Therapeutics is an attractive takeover target says analyst (Seeking Alpha)

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

 

Related Articles (HPTX)

Around the Web, We're Loving...