ARTICLE | Company News

FDA extends Xifaxan review for IBS

October 4, 2010 11:49 PM UTC

FDA extended the PDUFA date for an sNDA from Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) for Xifaxan rifaximin 550 mg tablets by three months to March 7, 2011, from Dec. 7. According to Salix, the agency requires additional time to review the application. The sNDA is under Priority Review to treat non-constipation irritable bowel syndrome (IBS) and IBS-related bloating. ...