Final FDA appro for Caraco's generic Metaglip

The US Food and Drug Administration has granted final approval for Caraco Pharmaceutical Laboratories' Abbreviated New Drug Application for glipizide/metformin HCl 2.5/250mg, 2.5/500mg and 5/500mg tablets, its generic equivalent to Bristol-Myers Squibb's Metaglip.

The drug is indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. It is also indicated as second-line therapy when diet, exercise and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes. According to IMS Health data for the 12 months ended September 2007, glipizide/metformin generic and branded Metaglip had combined annual sales of around $25.0 million.