FDA approves first generic Lexapro to treat depression, anxiety disorder

Teva/IVAX Pharmaceuticals gained FDA approval for the first generic version of Lexapro (Forest) to treat both depression and generalized anxiety disorder in adults. The company will have 180 days to exclusively sell the product.

It will be available in 5-mg, 10-mg, and 20-mg strengths.

"These psychiatric conditions can be disabling and prevent a person from doing every-day activities,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in a press release. “This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options.”

In the clinical trials for Lexapro, the most commonly observed adverse reactions were insomnia, ejaculation disorder, nausea, increase in sweating, fatigue and drowsiness, and decreased libido.

Escitalopram and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults aged 18 to 24 during initial treatment.

The warning also says data did not show this increased risk in those older than 24 years and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.