Irritable Bowel Syndrome

Cilansetron NDA granted priority review for IBS with diarrhea predominance

Published in Medical Letter on the CDC and FDA, October 3rd, 2004

Solvay Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review of the company's new drug application (NDA) for cilansetron, an investigational 5-HT3 receptor antagonist, being studied for the treatment of irritable bowel syndrome with diarrhea predominance (IBS-D) in men and women.

Products assigned for priority review by the FDA are those that appear to represent a potential therapeutic advance over existing therapies.

The company is seeking approval to manufacture and market cilansetron for the treatment of IBS-D in the United States.

"We are pleased...

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Source: Medical Letter on the CDC and FDA (2004-10-03)

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