Alfasigma announced the withdrawal of the New Drug Application (NDA) for Zelnorm® (tegaserod). The Company will no longer make the product available in the US marketplace.

Zelnorm, a selective serotonin-4 (5-HT4) receptor agonist, was initially approved in 2002 but was voluntarily withdrawn from the market in 2007 due to a potential safety issue regarding an increased risk of heart attack, stroke, and unstable angina.

In August 2019, Zelnorm was made available again for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women 65 years of age and younger. 

According to the Company, the decision to remove Zelnorm from the market effective June 30, 2022 was strictly business-related and was not based on the product’s efficacy or safety, or because of an imposed recall.

Patients will have access to Zelnorm for as long as the existing supply of product remains available. Health care professionals should consider alternative therapies.

Reference

Zelnorm® (tegaserod) notice of withdrawal from market. News release. Alfasigma USA, Inc. Accessed June 30, 2022. https://www.prnewswire.com/news-releases/zelnorm-tegaserod-notice-of-withdrawal-from-market-301578099.html