Final US approval for Teva's generic Lexapro

28 May 2006

Israel's Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted final approval for its Abbreviated New Drug Application to market its generic version of Forest Laboratories' Lexapro (escitalopram oxalate) tablets, 5mg, 10mg and 20mg.

Teva's AB-rated escitalopram oxalate tablets are indicated for the treatment of depression.

Teva is currently in patent litigation concerning this product in the US District Court for the District of Delaware. A suit was brought against its subsidiary, IVAX, in September 2003 involving its paragraph IV certification to US Patent No RE34,712. A trial was held in March 2006 and the post-trial briefing period ended on May 19.

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