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.