The U.S. FDA has given final approval to Israel-based Teva Pharmaceutical's abbreviated new drug application (ANDA) for the generic version of Forest Laboratories' Lexapro (escitalopram oxalate) tablets. Lexapro, which had sales of $464 million in the first quarter of 2006, is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of depression and generalized anxiety disorder.
Teva is currently in patent litigation over the product in the U.S. District Court for the District of Delaware, the company said. A suit was brought against Teva's subsidiary IVAX in September 2003 involving its paragraph IV certification to U.S. Patent RE34,712.
Lexapro has been prescribed to over 13 million patients in the U.S., where it is the fastest-growing medicine of its type. In clinical studies, the drug has been shown to be safe and well-tolerated, Teva noted.