FDA approves first generic version of depression drug Lexapro

Published October 24, 2015

The U.S. Food and Drug administration approved the first generic Lexapro (escitalopram tablets) for the treatment of both depression and generalized anxiety disorder in adults, the government organization announced Wednesday.

People with depression typically suffer from feelings of guilt and worthlessness that interfere with their ability to work, sleep, study, eat and enjoy other activities, while people with general anxiety disorder (GAD) suffer from exaggerated worry and tension. Both conditions can recur throughout a person’s lifetime.

“These psychiatric conditions can be disabling and prevent a person from doing every-day activities,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in an FDA 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.”

The FDA granted Teva Pharmaceutical Industries/IVAX Pharmaceuticals to market generic escitalopram in 5 milligram, 10 mg, and 20 mg strengths. Teva has been granted a 180-day period of generic drug exclusivity, meaning the FDA cannot approve another generic version of escitalopram.

Teva’s escitalopram tablets must meet the same quality standards as the brand-name drugs.

Click here to read more from the FDA.

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