Annual sales of the diabetes treatment are estimated at $430 million.
Teva Pharmaceutical Industries (Nasdaq:TEVA) announced on Friday that US Food and Drug Administration had granted final approval for its ANDA (abbreviated new drug application) for Metformin HCl Extended-Release Tablets, 500 mg. Teva said shipment of this product would begin immediately.
The approval follows a decision by Teva's strategic partner, IMPAX Laboratories, Inc. (Nasdaq:IPXL) to selectively waive its 180-day exclusivity in favor of Teva. The two companies will share in the profits of Teva's product as provided for in the Strategic Alliance Agreement signed in June 2001. Metformin HCl Extended-Release Tablets, 500 mg are the AB-rated generic equivalent of Bristol-Myers Squibb's Glucophage XR Tablets, 500 mg, a treatment for type 2 diabetes. Total annual sales of the product, including brand and generic sales, are approximately $430 million.
Published by Globes [online] - www.globes.co.il - on June 20, 2004