Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that based on a telephone conversation with the U.S. Food and Drug Administration (FDA) held last evening, the Company anticipates receiving a Complete Response Letter (CRL) on or before the March 7, 2011 PDUFA goal date for the supplemental New Drug Application (sNDA) 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. Until the Company is in receipt of the CRL, the Company has limited information as to its complete content.
The FDA issues a Complete Response Letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. Based on the telephone conversation referenced above, the Company is of the understanding 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 Complete Response Letter.