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Solvay Cilansetron Irritable Bowel NDA Will Include “Appropriate Use Plan”

Executive Summary

Solvay plans to submit a "comprehensive appropriate use plan" for cilansetron in conjunction with its upcoming NDA filing for the irritable bowel syndrome therapy

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FDA's Gastrointestinal Drugs and Drug Safety & Risk Management Advisory Committees are expected to discuss Solvay's NDA for the irritable bowel syndrome treatment cilansetron at a joint meeting, the company says. The committees are tentatively scheduled to meet jointly on March 9. FDA has extended its review of cilansetron by 90 days to April 1, 2005; the proposed trade name for the drug is Calmactin (1"The Pink Sheet" May 24, 2004, p. 32)...

FDA panel to review Solvay cilansetron

FDA's Gastrointestinal Drugs and Drug Safety & Risk Management Advisory Committees are expected to discuss Solvay's NDA for the irritable bowel syndrome treatment cilansetron at a joint meeting, the company says. The committees are tentatively scheduled to meet jointly on March 9. FDA has extended its review of cilansetron by 90 days to April 1, 2005; the proposed trade name for the drug is Calmactin (1"The Pink Sheet" May 24, 2004, p. 32)...

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