Glimepiride tablets are the generic equivalent of Aventis's Amaryl.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced today that the US Food and Drug Administration has granted tentative approval for the company's abbreviated new drug approval (ANDA) for Glimepiride tablets, 1 mg, 2 mg and 4 mg.
Teva's Glimepiride tablets are the AB-rated generic equivalent of Aventis' antidiabetic agent Amaryl tablets.
Teva stated that it anticipates final upon patent expiration on October 6, 2005.
The brand product has US annual sales of approximately $340 million.
Published by Globes [online], Israel business news - www.globes.co.il - on Tuesday, June 28, 2005