Last Updated: July 27, 2007 (Reuters Health)

Swiss drugmaker Novartis said on Friday it would make its bowel drug Zelnorm available to U.S. patients on a restricted basis after pulling the product from the market at the request of regulators.

Novartis said it has established a restricted access program for Zelnorm in cooperation with U.S. regulators.

The program is designed to help women under the age of 55 in the United States for whom no other treatment has provided satisfactory relief, as well as patients who showed improvement with prior Zelnorm treatment, Novartis said in a statement.

Novartis pulled Zelnorm from U.S. shelves earlier this year at the request of regulators because clinical trial data indicated a possible link to heart attacks and strokes.

That move was a blow to prospects for the drug, which had previously run into safety issues and was never approved for use in the European Union, and prompted the company to cut its 2007 sales forecast.

Date Posted: August 3, 2007