FDA approves Teva's glipizide-metformin HCL tablets

The drug is the generic equivalent of Bristol-Myers Squibb's Metaglip tablets for type 2 diabetes.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) today announced that the US Food and Drug Administration has granted final approval for the company's ANDA for glipizide and metformin hydrochloride tablets, 2.5 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg.

Teva stated that shipment of the product will begin immediately.

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 US annual sales of approximately $37 million.

Published by Globes [online], Israel business news - www.globes.co.il - on Monday, October 31, 2005

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