Alfasigma USA reintroduces Zelnorm

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Alfasigma USA reintroduces Zelnorm

By Sandra Levy - 08/16/2019
Alfasigma USA announced that Zelnorm (tegaserod) is available for irritable bowel syndrome with constipation, or IBS-C in adult women younger than 65 years old.

Alfasigma USA acquired the product from Sloan Pharma in July 2019.

“We are pleased to inform U.S. physicians and pharmacists about the reintroduction of Zelnorm and how Alfasigma USA is supporting the availability, access to, and appropriate use of this important medicine for the many patients who cope daily with an urgent need for new treatment options,” Alfasigma USA president and CEO Bryan Downey said.

Originally approved in 2002 as the first prescription medication for IBS-C, Zelnorm was voluntarily withdrawn from the market in 2007 due to concerns regarding possible cardiovascular risk. In March 2019, the product was approved for reintroduction in the United States for use in adult women under 65 years old with IBS-C, following a thorough safety review by the FDA and an FDA assembled Gastrointestinal Drugs Advisory Committee. The evaluation consisted of a review of clinical data from 29 placebo-controlled trials and post-marketing treatment outcome data, the company said.

“Zelnorm addresses an area of clear unmet medical need and there is a robust body of data supporting its safe and effective use when used as indicated for adult women in the United States suffering from IBS-C,” said John Kincaid, head of medical affairs at Alfasigma USA.