The US Food and Drug Administration has granted tentative approval for Teva Pharmaceutical's ANDA for Glimepiride Tablets, 1 mg, 2 mg and 4 mg. Final approval is anticipated upon patent expiration in October 6, 2005.
Teva's Glimepiride Tablets are the AB-rated generic equivalent of Aventis' antidiabetic agent Amaryl Tablets.
The brand product has US annual sales of approximately $340 million.