# Cilansetron delayed at the FDA - Joint Advisory Commitee Meeting Expected



## Jeffrey Roberts (Apr 15, 1987)

Solvay Pharmaceuticals, Inc. Announces 90-Day Extension of FDA Review of the New Drug Application for Cilansetron for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D)- Joint FDA Advisory Committee Meeting Expected - MARIETTA, Ga., Dec. 20 /PRNewswire/ -- Solvay Pharmaceuticals, Inc.announced today that the U.S. Food and Drug Administration (FDA) has extendedits review of the cilansetron new drug application (NDA). The reviewcompletion date, previously set for January 1, 2005, is now April 1, 2005.Cilansetron is expected to be discussed at a joint Gastrointestinal and DrugSafety and Risk Management Advisory Committee. Solvay Pharmaceuticals isseeking approval to market cilansetron, an investigational 5-HT3 receptorantagonist being studied for the treatment of IBS-D in men and women, andexpects to launch the product in the U.S. shortly following approval in 2005. "We continue to work closely with the FDA as they complete the reviewprocess for cilansetron," said Dr. Harold Shlevin, Solvay Pharmaceuticals,Inc. President and CEO. Solvay Pharmaceuticals' NDA submission includes a comprehensiveCilansetron Appropriate Use Program that was created through a collaborationof physicians, pharmacists, patients, and risk minimization experts andincludes an array of interrelated educational tools and specific promotionalstrategies, designed to facilitate access to cilansetron for the appropriatepatient. Solvay Pharmaceuticals, Inc. (http://www.solvaypharmaceuticals-us.com) ofMarietta, Georgia (USA), is a research-driven pharmaceutical company thatseeks to fulfill unmet medical needs in the therapeutic areas of cardiology,gastroenterology, mental health, women's health and a select group ofspecialized markets including men's health. It is a part of the global SolvayPharmaceuticals organization whose core activities consist of discovering,developing and manufacturing medicines for human use. Solvay Pharmaceuticals,Inc. is a subsidiary corporation of the worldwide Solvay Group of chemical andpharmaceutical companies headquartered in Brussels, Belgium.SOURCE Solvay Pharmaceuticals, Inc.


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