Salix confirms Xifaxan delay

As expected, FDA issued a complete response letter for Xifaxan rifaximin 550 mg tablets from Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) to treat irritable bowel syndrome (IBS). According to Salix, the agency requested retreatment information for the non-absorbed broad-spectrum antibiotic. Salix, which plans to request a meeting with FDA to discuss the sNDA, said it will provide its next update on Xifaxan in its 1Q11 earnings call, which is scheduled for early May. The sNDA is under review to treat non-constipation IBS and IBS-related bloating. Last month, Salix said it expected to receive the letter based on a telephone conversation with the agency. ...