# Salix Pharmaceuticals says it expects the U.S. FDA to decline approval of its drug Xifaxan in its current form to treat non-constipation IBS



## Jeffrey Roberts (Apr 15, 1987)

Feb 24 - Salix Pharmaceuticals said it expects the U.S. Health Regulators (FDA) to decline approval of its drug Xifaxan in its current form to treat non-constipation irritable bowel syndrome (IBS).Citing a telephone call with the U.S. Food and Drug Administration, Salix said the regulator thinks Xifaxan is not ready for approval, and sought additional treatment information.The company expects to receive a complete response letter on the drug, which is already approved for two other indications, by March 7.The FDA issues "complete response letters" when it has reviewed a file but requires more information and will not approve it based on current information.Salix said it would consider further action after it receives the letter.© Copyright 2011 Thomson Reuters


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