Salix submits efficacy supplement for XIFAXAN NDA for Non-C IBS and IBS-related bloating

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company has submitted an efficacy supplement to NDA 21-361 for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating. By regulation, the Food and Drug Administration (FDA) has 60 days to conduct a filing review to determine if the application is sufficiently complete to permit a substantive review. Salix has requested Priority Review for this application. By regulation, the FDA should determine the review classification for this application within the 60-day period referenced above.


Salix Pharmaceuticals, Ltd.,


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