Regulatory Focus™ > News Articles > FDA Approves Generic Lexapro

FDA Approves Generic Lexapro

Posted 14 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) today approved Israeli pharmaceutical manufacturer Teva Pharmaceutical Industries to legally market generic Lexapro for depression and generalized anxiety disorder in adults.

Teva has been granted 180 days of marketing exclusivity, during which FDA is not allowed to approve any other generic version of Lexapro, originally manufactured by Forest Laboratories.

Teva's Abbreviated New Drug Application (ANDA) for Lexapro was originally cleared in May 2006, but Forest Laboratories was successful in extending its patent until 14 March 2012.

Read more:

FDA - FDA approves first generic Lexapro to treat depression and anxiety disorder

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