Alfasigma Withdraws Zelnorm from Market

Alfasigma has withdrawal Zelnorm (tegaserod) from the U.S. market. Alfasigma USA will no longer make the product available in the U.S. marketplace. Company officials said in a press release this is a business decision and not because of efficacy or safety.

Patients will continue to have access to the medication as long as supply.

Zelnorm 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.

Alfasigma acquired Zelnorm in 2019 from Sloan Pharma. No generics are available.

Zelnorm, developed by Novartis, was first approved by the FDA in 2002. But it was voluntarily withdrawn from the market in 2007 because of concerns about possible cardiovascular risk. It had remained available in the United States through an expanded access program authorized by the FDA.

In early 2019, Zelnorm was approved by the FDA for reintroduction for use in adult women with irritable bowel syndrome with constipation. The approval to reintroduce the therapy came after a safety review by the FDA and an FDA-assembled Gastrointestinal Drugs Advisory Committee (GIDAC). The evaluation consisted of a review of the clinical data from 29 placebo-controlled trials and post-marketing treatment outcomes data.

Alfasigma had relaunched Zelnorm in August 2019.