Salix Responds To FDA's XIFAXAN 550mg Complete Response Letter

(RTTNews) - Salix Pharmaceuticals, Ltd. (SLXP) Tuesday said on August 29, 2014, it responded to the Complete Response Letter or CRL issued by the FDA on March 7, 2011, regarding the company's supplemental New Drug Application or sNDA for XIFAXAN 550 mg tablets for the proposed indication of the treatment of irritable bowel syndrome with diarrhea or IBS-D. The FDA will have six months to issue a response.

Earlier, during the original review of Salix's sNDA, the FDA had determined that it is important in a chronic condition such as IBS to have information about how a product that is meant for short course administration in order to confer prolonged benefit should be administered beyond the first cycle of use once symptoms reappear. Also, the FDA determined that patients and their health care providers should have information on the safety and effectiveness of this re-treatment. This information was conveyed to Salix in a March 7, 2011, CRL.