Salix Pharmaceuticals Ltd. (SLXP) said the U.S. Food and Drug Administration or FDA issued a Complete Response Letter or CRL on March 7, 2011 for the supplemental New Drug Application or sNDA for XIFAXAN 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome or Non-C IBS and IBS-related bloating.
The company added that CRL reconfirms its understanding that the FDA deems the XIFAXAN 550 mg sNDA for non-C IBS is not ready for approval primarily due to a newly expressed need for retreatment information. The company received the CRL at around 8:00 p.m. ET on Monday, March 7, 2011.
During this time, the company plans to request a Type A meeting with the Agency to discuss the XIFAXAN 550 mg sNDA for non-C IBS and also intends to provide its next update during its first quarter 2011 earnings call to be scheduled for early May 2011.
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