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Generic Lexapro Approved for Adult Depression, Anxiety


March 14, 2012 — The US Food and Drug Administration (FDA) today approved escitalopram tablets for the treatment of adults with depression and general anxiety disorder, making this the first generic version of Lexapro (Forest Pharmaceuticals) to receive FDA approval for treating both disorders.
"These psychiatric conditions can be disabling and prevent a person from doing everyday activities," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a release.
"This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options," added Dr. Woodcock.
Today's approval will allow Teva Pharmaceutical Industries/IVAX Pharmaceuticals to market the generic tablets in dosages of 5, 10, and 20 mg. In addition, the FDA granted a 180-day period of generic drug exclusivity to Teva.
The most common treatment-related adverse effects reported in past studies that evaluated this medication have included insomnia, decreased libido, ejaculation disorder, excessive sweating, fatigue, nausea, and drowsiness.
As with other antidepressants, escitalopram comes with a boxed warning and patient medication guide calling for careful monitoring during the start of use and reporting that there is an increased risk for suicidal ideation in those younger than 24 years.
However, the warning also notes that this risk has not been found in those older than 24 years and that those older than 64 years have actually seen a decrease in these behaviors.

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