Ranbaxy Slated For Generic Nexium Approval
This article was originally published in PharmAsia News
Executive Summary
U.S. FDA Feb. 7 granted Ranbaxy a tentative approval for 20 mg and 40 mg delayed-release capsules of esomeprazole, a generic version of AstraZeneca's Nexium. The proton pump inhibitor is scheduled to lose U.S. exclusivity in October 2009. AstraZeneca reported $3.4 billion in U.S. Nexium sales for 2007. Gurgaon, India-based Ranbaxy claims it has first-to-file status for esomeprazole, which would give the company 180-day marketing exclusivity