Is Zelnorm back on the market?

Yes. The FDA approved the reintroduction of Zelnorm (tegaserod) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65 years of age, in late March 2019.

It is expected to become available in the months following the announcement.

• Zelnorm was originally approved by the FDA in 2002 for the treatment of IBS-C in women.
• In March 2007, Zelnorm was voluntarily withdrawn from the U.S. market because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with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 those who were treated with a placebo.
• In July 2007, the FDA announced that it was permitting the restricted use of Zelnorm for certain patients when there was no satisfactory alternative treatment available.
• 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.