Mylan Laboratories Inc has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) 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. Carvedilol tablets had US sales of approximately $1.65 billion for the 12 months ending June 30, 2007, for the same strengths.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Ltd, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.