Teva receives FDA approval for amoxicillin 500 and 875 mg tablets

The United States Food and Drug Administration (FDA) has granted Teva Pharmaceutical Industries Ltd. (Jerusalem) final approval to manufacture and market Amoxicillin 500 and 875 mg Tablets, both of which are intended for twice-daily dosage. The approval was the first ever for these strengths of generic amoxicillin.

Teva's Amoxicillin is the generic version of SmithKline Beecham's Amoxil, which is indicated for the treatment of infections due to susceptible organisms. The 500- and 875-mg strengths of Amoxil accounted for approximately $34 million in U.S. sales in 1999.

Teva intends to launch the product imminently.

Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company with over 80% of its sales outside Israel, mainly in North America and Europe. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients.

For more information, contact Bill Fletcher, president and CEO of Teva North America, at 215-591-3000.

Edited by Jim Pomager
Assistant Editor, Pharmaceutical Online