Caraco Pharmaceutical Laboratories has received FDA's final approval for the company's abbreviated new drug application for Glipizide/Metformin hydrochloride tablets, 2.5/250mg, 2.5/500mg and 5/500 mg.
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Glipizide or Metformin HCl 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.
Daniel Movens, CEO of Caraco, said: “Our 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.”
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