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Novartis’ Zelnorm is back…kind of

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis' 5-HT4 agonist will be available under a treatment investigational new drug protocol to treat irritable bowel syndrome with constipation and chronic idiopathic constipation in women under 55, FDA announces July 27. Marketing of tegaserod was suspended in March after a pooled data analysis of 29 clinical trials revealed a higher chance of heart attack, stroke and worsening chest pain in patients treated with Zelnorm compared to those on placebo. "Novartis and the FDA are moving forward with this program because of requests from physicians and patients following the marketing suspension of Zelnorm in March 2007," Novartis said in a July 27 statement...

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