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.