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news.North Carolina-based Salix Pharmaceuticals anticipates receiving a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) on or before 7 March 2011 PDUFA goal date for the supplemental New Drug Application (sNDA) for XIFAXAN (rifaximin) 550 mg tablets.
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XIFAXAN is indicated for the treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.
Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens.
Salix is of the opinion that the FDA deems the XIFAXAN 550 mg sNDA is not ready for approval primarily due to a newly expressed need for retreatment information.
The company will consider next steps with respect to the XIFAXAN 550 mg sNDA for non-C-IBS following receipt of a CRL.
Salix acquired rights to market rifaximin in North America from Alfa Wassermann.