Teva Pharmaceutical Industries
said Monday it received final approval from the the US Food and Drug Administration (FDA) for its ANDA for glipizide and metformin hydrochloride tablets.
The company said that shipment will begin immediately for the 2.5 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg tablets.
Teva's tablets are the AB-rated generic equivalent of Bristol-Myers Squibb's Metaglip(R) Tablets, which are used 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 annual sales of approximately $37 million.