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
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