The US 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 US sales of approximately $1.14 billion as of December 2005, states a Mylan release.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries: Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.