Caraco gains FDA approval to market generic diabetes drug

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The FDA has granted final approval for the Caraco Pharmaceutical Laboratories’ Abbreviated New Drug Application (ANDA) for Glipizide/Metformin Hydrochloride Tablets, 2.5/250 mg, 2.5/500 mg and 5/500 mg to market generic version of Bristol-Myers Squibb’s Metaglip diabetes drug.

Glipizide/Metformin HCl is indicated as initial therapy, as an adjunct to diet and exercise, to improve glycemic control with type 2 diabetes patients, whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, according to the Detroit-based Caraco. 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, the company said.

The company said its generic Glipizide/Metformin HCl is the bioequivalent to Metaglip, a registered trademark of Bristol-Myers Squibb. According to IMS Health Data, for the twelve months ended September 2007, Glipizide/Metformin HCl generic and brand products (Metaglip) combined had annual sales of approximately $25 million.

Daniel H. Movens, Caraco's CEO, said that the company’s “focus continues to be working towards expanding our product line effectively, including products that are already available generically in the market that potentially can add measurable value.”