Mylan announces FDA approval for Glipizide and Metformin Hydrochloride tablets

Mylan Laboratories has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Glipizide and Metformin Hydrochloride Tablets in 2.5 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg strengths.

Glipizide and Metformin Hydrochloride Tablets are the generic version of Bristol Myers Squibb's Metaglip(TM) Tablets. Glipizide and Metformin Hydrochloride Tablets had U.S. sales of approximately $29 million for the same strengths for the 12-month period ended Dec. 31, 2006, according to IMS Health.

This product will be shipped immediately.

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.