ARTICLE | Company News

FDA extends review of Salix's 550 mg rifaximin

November 11, 2009 1:49 AM UTC

Salix Pharmaceuticals Ltd. (NASDAQ: SLXP) disclosed that FDA extended the PDUFA date for an NDA for 550 mg rifaximin by three months to March 24, 2010, from Dec. 24. The NDA is under Priority Review for the maintenance of remission of hepatic encephalopathy (HE). In August, Salix said the agency was planning to schedule an advisory committee meeting in late February 2010 to discuss the NDA, which the company said at the time signaled that the PDUFA date would be delayed. The company said a date has not yet been set for the meeting, which will be conducted by FDA's Gastrointestinal Advisory Committee. ...