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Teva receives approval for Glipizide, Metformin
New York, Oct. 31 - Teva Pharmaceutical Industries Ltd. said it received approval from the Food and Drug Administration for its ANDA for pizide and Metformin Hydrochloride tablets, 2.5 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg.
Shipment will begin immediately, the Jerusalem, Israel, generic pharmaceutical company said.
Glipizide and Metformin Hydrochloride tablets are the AB-rated generic equivalent of Bristol-Myers Squibb's Metaglip Tablets, which are indicated as an adjunct to diet and exercise in type 2 diabetes, as initial therapy or as a second-line therapy when response to sulfonylurea or metformin is inadequate.
The brand product has U.S. annual sales of $37 million, Teva said.
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