PITTSBURGH, Sept. 6 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. 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(R) Tablets. Carvedilol Tablets had U.S. sales of approximately $1.65 billion for the 12 months ending June 30, 2007, for the same strengths.
This product has shipped.
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 Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.
For more information about Mylan, please visit www.mylan.com.
Mylan Laboratories Inc.
CONTACT: Kris King of Mylan Laboratories Inc., +1-724-514-1800
Web site: http://www.mylan.com/