Roxane Orlaam
Executive Summary
FDA action on sNDA for revised safety labeling for the anti-addiction agent is expected Oct. 26, the company says. A supplement was submitted April 25 following cases of torsades de pointes in patients taking Orlaam (leva-alpha-acetylmethadol). Seven cases of known or suspected torsades de pointes have occurred in the U.S. out of the 10,000 patients treated with Orlaam since launch in 1993, the company indicates