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Zelnorm FDA Approval History

Last updated by Judith Stewart, BPharm on April 3, 2019.

FDA Approved: Yes (First approved July 24, 2002)
Brand name: Zelnorm
Generic name: tegaserod
Dosage form: Tablets
Company: US WorldMeds, LLC
Treatment for: Irritable Bowel Syndrome

Zelnorm (tegaserod) is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C)

Zelnorm was originally approved by the FDA in 2002 for the treatment of IBS-C in women. It was voluntarily withdrawn from the U.S. market in March 2007 because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with treatment with a placebo. In July 2007, the FDA announced that it was permitting the restricted use of Zelnorm under a treatment investigational new drug (IND) protocol, which is a mechanism for providing eligible patients with investigational drugs for the treatment of serious and life-threatening illnesses for which there are no satisfactory alternative treatments.

In March 2019, the FDA approved the reintroduction of Zelnorm for the treatment for Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65. Approval came after a complete safety review by the FDA and the Gastrointestinal Drugs Advisory Committee (GIDAC). The review focused on the evaluation of clinical data from 29 placebo-controlled trials and newly-available sources of treatment outcome data. A positive GIDAC vote and FDA review both supported the reintroduction of Zelnorm for appropriate IBS-C patients.

Development timeline for Zelnorm

Apr  1, 2019Approval FDA Approves the Reintroduction of Zelnorm (tegaserod) for Irritable Bowel Syndrome with Constipation (IBS-C) in Women Under 65

Further information

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