1. Pink Sheet

Zelnorm Returning To US Market With Broad IBS-C Indication

 
• By Michael Cipriano

US FDA limiting use of Zelnorm, originally pulled from the market in 2007 by its then-sponsor Novartis, to adult women who are at low CV risk, but tegaserod is not restricted to patients who are severely symptomatic for IBS-C. 

The Photo Of Large Intestine Is On The Woman's Body. People With Stomach Ache Problem Concept. Female Anatomy

The US FDA has given Zelnorm (tegaserod maleate) the green light to return to the US market with a broad indication for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C) who are at low cardiovascular (CV) risk.

The new label for Zelnorm, a serotonin-4 (5-HT4) receptor agonist now owned by US WorldMeds LLC, contains a contraindication for patients with a history of myocardial infarction, stroke,...

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