- Salix Pharmaceuticals introduces Rx topical foam to treat a form of inflammatory bowel disease
- Senate passes Drug Quality and Security Act
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- 21 health industry groups address FDA on proposed changes to generic drug label rules
- FDA advisory panel to consider OTC status of NSAIDs
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.
A complete response letter indicates that the FDA has completed review of a regulatory approval application, but issues remain that preclude final approval. Salix said it planned to request a meeting with the agency to discuss the drug.