Mylan announces tentative approval for Carvedilol tablets

By Elaine Rigoli

Tampa, Fla., Feb. 23 - Mylan Laboratories, Inc. announced Thursday that the Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s abbreviated New Drug Application for Carvedilol tablets 3.125 mg, 6.25 mg, 12.5 mg and 25 mg.

Carvedilol tablets are the generic version of GlaxoSmithKline's Coreg tablets, which had annual U.S. sales of about $1.14 billion as of December, according to a Mylan news release.

Mylan is a Pittsburgh-based pharmaceutical company that develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.

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