Solvay Cilansetron NDA Filing Will Feature "Appropriate Use Plan" For Irritable Bowel Syndrome Drug
This article was originally published in The Pink Sheet Daily
Executive Summary
Proposed risk management plan for Lotronex cousin will likely include "novel educational approach" for physicians and patients, Solvay said. Company plans to file NDA for treatment of diarrhea-predominant IBS in men and women in the second quarter.
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Solvay Expects Advisory Cmte. Review For Irritable Bowel Agent Cilansetron
FDA’s Gastrointestinal Drugs and Drug Safety & Risk Management Advisory Committees are expected to discuss cilansetron at a March 9 joint meeting. The agency extends the Jan. 1 user fee deadline for the NDA by 90 days to April 1.
Solvay Expects Advisory Cmte. Review For Irritable Bowel Agent Cilansetron
FDA’s Gastrointestinal Drugs and Drug Safety & Risk Management Advisory Committees are expected to discuss cilansetron at a March 9 joint meeting. The agency extends the Jan. 1 user fee deadline for the NDA by 90 days to April 1.
Solvay Submits Cilansetron NDA For Irritable Bowel Syndrome
Assuming a standard review clock, cilansetron’s user fee date would be May 1, 2005. The application for use in diarrhea-predominant IBS includes an “extensive appropriate use plan,” Solvay says. The drug’s proposed trade name is Calmactin.