Mylan says gets tentative FDA Valtrex OK |
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Published
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Wed, 31 Jan 2007 17:49
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PITTSBURGH (AFX) - Mylan Laboratories Inc. said Wednesday the Food and Drug Administration gave tentative approval to the drug maker's generic version of GlaxoSmithKline PLC's Valtrex herpes treatment.The tentative approval applies to 500-milligram and 1000-milligram tablets of valacyclovir hydrochloride, the active ingredient in Valtrex.Tentative approvals are given when a drug maker's marketing application is in order but legal issues need to be resolved or valid patents are still in force. Patents for Valtrex begin expiring in June 2009.U.S. sales of Valtrex for the nine months ended Sept. 30 totaled $819 million, according to GlaxoSmithKline.Mylan shares fell 8 cents to $21.95 in midday trading on the New York Stock Exchange.Copyright 2006 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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