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Salix issued CRL for Xifaxan
RALEIGH, N.C. — The Food and Drug Administration declined to approve a drug made by Salix Pharmaceuticals for irritable bowel syndrome, Salix said Tuesday.
The FDA issued a complete response letter to Salix for Xifaxan (rifaximin), a treatment for nonconstipation IBS and IBS-related bloating. Salix said it had anticipated that it would receive the letter based on an understanding that the agency needed more information related to retreatment.
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New diabetes drug accepted for review by FDA
PRINCETON, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a Type 2 diabetes drug from Bristol-Myers Squibb and AstraZeneca, the two drug makers said Tuesday.
The FDA accepted the application for dapagliflozin, an investigational drug for adults with the disease. The Centers for Disease Control and Prevention estimated that 1-in-11 U.S. adults has diabetes, with 90% to 95% of them having Type 2 diabetes.
The agency expects to take action on the application in late October.