Calmactin FDA Approval Status

FDA Approved: No
Brand name: Calmactin
Generic name: cilansetron
Company: Solvay Pharmaceuticals, Inc.
Treatment for: Irritable Bowel Syndrome

Calmactin (cilansetron) is a 5-HT3 receptor antagonist in development for the treatment of irritable bowel syndrome with diarrhea predominance (IBS-D).

In April 2005, Solvay Pharmaceuticals, Inc. announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for Calmactin (cilansetron) had not been approved.

Development timeline for Calmactin

Date	Article
Nov 29, 2005	Cilansetron; Solvay Pharmaceuticals Suspends Registration Activites in the U.S., While Discussions in Europe Continue
Apr 1, 2005	FDA Requests Further Data on Cilansetron, Solvay's Proposed Treatment for Irritable Bowel Syndrome with Diarrhea Predominance (IBS-D)
Dec 20, 2004	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)
Sep 1, 2004	Cilansetron NDA Filing Accepted for Priority Review by the FDA for the Treatment of Irritable Bowel Syndrome with Diarrhea Predominance
Jul 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

Further information

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