FDA panel to review Solvay cilansetron
Executive Summary
FDA's Gastrointestinal Drugs and Drug Safety & Risk Management Advisory Committees are expected to discuss Solvay's NDA for the irritable bowel syndrome treatment cilansetron at a joint meeting, the company says. The committees are tentatively scheduled to meet jointly on March 9. FDA has extended its review of cilansetron by 90 days to April 1, 2005; the proposed trade name for the drug is Calmactin (1"The Pink Sheet" May 24, 2004, p. 32)...