Mylan gets tentative FDA Depakote OK |
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Wed, 14 Mar 2007 15:17
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PITTSBURGH (AP) - Drug maker Mylan Laboratories Inc. said Wednesday that its Mylan Pharmaceuticals unit received tentative approval from the Food and Drug Administration to sell a generic version of Abbott Laboratories' Depakote tablets.Specifically, the tentative approval applies to 250-milligram and 500-milligram tablets of extended-release divalproex sodium, the active ingredient in Depakote. The drug is used to treat migraine headaches, several types of epileptic disorders, and manic episodes associated with bipolar disorder.Tentative approvals are given to generic drugmakers when patents on the specific drug are still outstanding. Abbott has patent protection on Depakote until January 2008.Abbott reported total U.S. Depakote sales of $1.23 billion in 2006.In January, Israeli drug maker Teva Pharmaceutical Industries Ltd. also received a tentative FDA approval for generic versions of Depakote for the same strengths plus a 125-milligram strength.Mylan shares fell 4 cents to $19.52 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 This material may not be published, broadcast, rewritten, or redistributed.
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