Salix Pharmaceuticals Ltd. (SLXP) Monday said FDA has extended the Prescription Drug User Fee Act goal date for the Agency's Priority Review of the efficacy supplement to NDA 21-361 for XIFAXAN 550 mg Tablets by three months to March 7, 2011. The previous goal date was December 7, 2010.
XIFAXAN, or rifaximin 550 mg is indicated for reduction in risk of overt hepatic encephalopathy recurrence in patients of or greater than 18 years of age. It is used for the proposed indication of the treatment of non-constipation irritable bowel syndrome and IBS-related bloating.
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