Salix Pharmaceuticals announced that a New Drug Application (NDA) has been submitted to the FDA seeking approval of Xifaxan (rifaximin 550 mg tablets) for the treatment of patients with non-constipation irritable bowel syndrome (non-C IBS) and IBS-related bloating. Salix has requested Priority Review for this application. By regulation, the FDA has 60 days to conduct a filing review to determine if the application is sufficiently complete to permit a substantive review.
Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens. Xifaxan 550mg tablets are currently indicated for reduction in risk of overt hepatic encephalopathy recurrence in patients ≥18yrs of age. Xifaxan 200mg tablets are currently indicated for the treatment of travelers’ diarrhea due to noninvasive E. coli.
For more information call (800) 508-0024 or visit www.salix.com.