Caraco reports U.S. FDA approval to market generic glucotrol

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Caraco Pharmaceutical Laboratories, Ltd., (CPD) announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the company’s Abbreviated New Drug Application (ANDA) for Glipizide tablets.

Caraco’s Glipizide tablets are the generic equivalent of Pfizer’s Glucotrol, an antidiabetic drug, which is indicated as an adjunct to diet for the control of hyperglycemia and the associated symptomatology in patients with non-insulin-dependent diabetes mellitus, (NIDDM), Type-2 diabetes. Caraco Pharma will manufacture and market both 5mg and 10mg tablets.

Daniel H. Movens, Caraco’s CEO, said, “We are pleased to gain this approval and add this to our growing portfolio of products that we market in the U.S. Glipizide will complement our current product mix by adding another anti-diabetic to our line. We plan to launch this product to the market immediately.”

“This approval brings our total marketed product selection to 21 different products represented by 45 strengths,” he added.

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures and distributes generic and private-label prescription pharmaceuticals to the nation’s wholesalers, distributors, drugstore chains and managed care providers.

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