FDA approves Teva's generic Lexapro

Forest Laboratories' Lexapro is used to treat depression.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has announced that the US Food and Drug Administration (FDA) has granted final approval for its abbreviated new drug application (ANDA) to market its generic version of Forest Laboratories, Inc.’s Lexapro (Escitalopram Oxalate) Tablets, 5 mg, 10 mg and 20 mg.

Teva’s AB-rated Escitalopram Oxalate Tablets are indicated for the treatment of depression. The original drug had sales of $464 million in the first quarter.

Teva said it was currently in patent litigation over this product in the US District Court for the District of Delaware. A suit was brought against Teva’s subsidiary IVAX in September 2003 involving its paragraph IV certification to US Patent RE34,712.

A trial was held in March 2006 and the post-trial briefing period ended on May 19th.

Published by Globes [online], Israel business news - www.globes.co.il - on May 23, 2006

© Copyright of Globes Publisher Itonut (1983) Ltd. 2006

Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2018