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Solvay withdraws cilansetron NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Solvay has withdrawn its NDA for its irritable bowel syndrome agent cilansetron, the firm says Nov. 29. The company determined that "the amount of clinical work requested" as well as the potential IBS market for the 5-HT3 receptor antagonist suggested the company should focus on development of other compounds. Cilansetron was deemed "not approvable" March 23; FDA requested additional clinical trials to support an IBS indication for both women and men (Pharmaceutical Approvals Monthly April 2005, In Brief). Solvay said it is open to divesting cilansetron to another company...

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