CalmactinTreatment for Irritable Bowel Syndrome
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., December 20, 2004 -- Solvay Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended its review of the cilansetron new drug application (NDA). The review completion date, previously set for January 1, 2005, is now April 1, 2005. Cilansetron is expected to be discussed at a joint Gastrointestinal and Drug Safety and Risk Management Advisory Committee. Solvay Pharmaceuticals is seeking approval to market cilansetron, an investigational 5-HT3 receptor antagonist being studied for the treatment of IBS-D in men and women, and expects 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 review process for cilansetron," said Dr. Harold Shlevin, Solvay Pharmaceuticals, Inc. President and CEO.
Solvay Pharmaceuticals' NDA submission includes a comprehensive Cilansetron Appropriate Use Program that was created through a collaboration of physicians, pharmacists, patients, and risk minimization experts and includes an array of interrelated educational tools and specific promotional strategies, designed to facilitate access to cilansetron for the appropriate patient.
Solvay Pharmaceuticals, Inc. of Marietta, Georgia (USA), is a research-driven pharmaceutical company that seeks to fulfill unmet medical needs in the therapeutic areas of cardiology, gastroenterology, mental health, women's health and a select group of specialized markets including men's health. It is a part of the global Solvay Pharmaceuticals 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 and pharmaceutical companies headquartered in Brussels, Belgium.
Posted: December 2004
- Cilansetron; Solvay Pharmaceuticals Suspends Registration Activites in the U.S., While Discussions in Europe Continue - November 29, 2005
- FDA Requests Further Data on Cilansetron, Solvay's Proposed Treatment for Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D) - April 1, 2005
- Cilansetron NDA Filing Accepted for Priority Review by the FDA for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance - September 1, 2004
- Solvay Pharmaceuticals, Inc. Submits New Drug Application to the United States Food and Drug Administration for Cilansetron toTreat Irritable Bowel Syndrome with Diarrhea Predominance in Men and Women - July 1, 2004