Salix Pharmaceuticals, Ltd. (SLXP) Submits Response To XIFAXAN® 550mg Complete Response Letter Regarding Repeat Treatment For Irritable Bowel Syndrome With Diarrhea
9/2/2014 11:53:41 AM
RALEIGH, N.C.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) announced today that on August 29, 2014, it submitted its response to the March 7, 2011, Food and Drug Administration (FDA) Complete Response Letter (CRL) regarding the Company’s supplemental New Drug Application (sNDA) for XIFAXAN® 550 mg tablets for the proposed indication of the treatment of irritable bowel syndrome with diarrhea or IBS-D. Upon receipt of Salix’s response, the FDA will have six months to issue a response.
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