Metformin hydrochloride extended release tablets are the generic equivalent of Bristol-Myers Squibb's Glucophage XR for type 2 diabetes.
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA) announced today that the US Food and Drug Administration (FDA) has granted tentative approval for its ANDA for metformin hydrochloride extended release tablets, 750 mg.
Teva's Metformin HCl ER tablets, 750 mg, are the AB-rated generic equivalent of Bristol-Myers Squibb's Glucophage XR Tablets, 750 mg, a product indicated for the treatment of type 2 diabetes. Final approval is anticipated upon the expiration of the exclusivity period.
Teva noted that the brand product has annual sales of approximately $27 million.
Teva closed up 0.05 points on Nasdaq yesterday, at $29.23. Teva is currently down 0.93% on the TASE on NIS 23.88 million turnover.
Published by Globes [online], Israel business news - www.globes.co.il - on Tuesday, December 14, 2004