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Pharma Watch: FDA Approves Mylan For Herpes Generic

May 27, 2010 (FinancialWire) — Mylan Inc. (NASDAQ: MYL) said that its Matrix Laboratories subsidiary has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Valacyclovir Hydrochloride Tablets, 500 mg and 1000 mg , the generic version of GlaxoSmithKline's (NYSE: GSK) Valtrex, a treatment for the herpes virus infection.

According to the company, the product is being distributed by Mylan Pharmaceuticals Inc. and is shipping to customers.

Valacyclovir Hydrochloride Tablets had U.S. sales of around $2.15 billion for the 12 months ending March 31, 2010, according to IMS Health.

Currently, Mylan has 142 ANDAs pending FDA approval representing $95.6 billion in annual brand sales, according to IMS Health.

Pennsylvania-based Mylan is a generic and specialty pharmaceutical firm with customers in more than 140 countries and territories.

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