Ranbaxy gets tentative Ambien FDA OK |
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Published
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Fri, 16 Mar 2007 16:18
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PRINCETON, N.J. (AP) - Indian drug maker Ranbaxy Laboratories Ltd. said Friday it got tentative U.S. approval for a generic version of sleep aid Ambien sold by French rival Sanofi-Aventis SA.Ranbaxy said it received the provisional Food and Drug Administration go-ahead for 5-milligram and 10-milligram tablets of zolpidem tartrate, the active ingredient in Ambien. Tentative approvals are given when a company's marketing application is in order but patent or legal issues prevent a full approval.The company said it will launch the drug after receiving final approval from the FDA. Patent protection for Ambien is set to expire on April 21. Ranbaxy also said it plans to make the product at its Brunswick, N.J., facility.In the most recent quarter, Sanofi-Aventis reported total U.S. Ambien sales of 532 million euros (about $709 million).U.S. shares of Sanofi-Aventis rose 22 cents to $42.12 in morning trading on the New York Stock Exchange.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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Ranbaxy gets US FDA approval to make generic version of Sanofi-Aventis' Ambien 