FDA grants final approval for Caraco's generic Metaglip

DETROIT The Food and Drug Administration has granted final approval to Caraco Pharmaceutical Laboratories application for glipizide/metformin hydrochloride tablets 2.5/250 mg, 2.5/500 mg and 5/500 mg.

The drugs are a generic version of Bristol-Myers Squibb’s drug Metaglip. It 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 data, for the 12 months that ended September 2007, the generic and brand products of the drug had combined annual sales of about $25 million.