Solvay Preparing Announcement On Cilansetron NDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Solvay receives a response letter from FDA one week ahead of the user fee deadline for the irritable bowel syndrome product. Solvay is currently assessing the letter's contents, the company says.
|
Solvay has received a response letter from FDA on its NDA for cilansetron ahead of the April 1 user fee deadline for the irritable bowel syndrome product. The company said it received a letter from FDA March 23, and it is currently assessing the contents. Solvay said it plans an announcement on the product April 1. Solvay is seeking an indication for cilansetron for diarrhea-predominant irritable bowel syndrome in women and men. The company originally expected an advisory committee review of the application, but Solvay said in February that it no longer anticipated a meeting (1 (Also see "Solvay No Longer Expects Advisory Cmte. For Irritable Bowel Drug Calmactin" - Pink Sheet, 2 Feb, 2005.)). Cilansetron is a 5-HT-3 receptor antagonist like GlaxoSmithKline's IBS product Lotronex (alosetron), which was reintroduced under a restricted access program after being withdrawn from the market for safety reasons. Solvay submitted an "appropriate use program" with its cilansetron NDA. The NDA was submitted July 1, 2004, and granted priority review status. FDA later extended the review clock by 90 days (2 (Also see "Solvay Expects Advisory Cmte. Review For Irritable Bowel Agent Cilansetron" - Pink Sheet, 20 Dec, 2004.)). - Elizabeth Walker |