Mylan Laboratories Inc. has received final approval from the US 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 tablets. Glipizide and Metformin Hydrochloride Tablets had US sales of approximately $29 million for the same strengths for the 12-month period ended Dec. 31, 2006, according to IMS Health.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries Mylan Pharmaceuticals Inc.