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FDA Approves First Generic Form of Escitalopram

March 5, 2012

The first generic formulation of the selective serotonin reuptake inhibitor escitalopram has been approved by the Food and Drug Administration, the agency announced on March 14.

In a statement, the FDA said that generic escitalopram – in 5-mg, 10-mg, and 20-mg doses – manufactured by Teva Pharmaceutical Industries/IVAX Pharmaceuticals, has been approved for treating depression and generalized anxiety disorder in adults. Escitalopram initially was approved in 2002 and is marketed as Lexapro by Forest Laboratories.

Teva has 180 days of generic drug “exclusivity,” during which time the FDA cannot approve any other generic formulation of escitalopram, the statement said.



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