The US Food and Drug Administration has granted final approval for Teva Pharmaceutical Industries Ltd ANDA for glipizide and metformin hydrochloride tablets. Shipment of this product will begin immediately.
Teva's 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, maintains a company release.
The brand product has US annual sales of approximately $37 million.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.