Solvay cilansetron "not approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Solvay's irritable bowel syndrome therapy Calmactin (cilansetron) is "not approvable" March 23, one week ahead of the product's April 1 user fee date. FDA is requesting additional clinical trials to support an indication for treatment of IBS in both women and men. Solvay says it notified the agency March 30 of its intent to amend the cilansetron NDA. The decision follows the firm's February announcement that it no longer expected the Gastrointestinal Drugs Advisory Committee to review the 5-HT3 antagonist. The meeting was tentatively set for March 9 (1Pharmaceutical Approvals Monthly February 2005, p. 31)...