FDA approves first generic Lexapro to treat depression and anxiety disorder

FDA approves first generic Lexapro to treat depression and anxiety disorder



For Immediate Release: March 14, 2012

The U.S. Food and Drug Administration approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults.

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

Teva Pharmaceutical Industries/IVAX Pharmaceuticals gained FDA approval to market generic escitalopram in 5 milligram, 10 mg, and 20 mg strengths.

In the clinical trials for Lexapro, the most commonly observed adverse reactions were: sleeplessness (insomnia), ejaculation disorder, nausea, increase in sweating, fatigue and drowsiness, and low sex drive (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 ages 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.

Teva has been granted a 180-day period of generic drug exclusivity, which means that FDA cannot approve another generic version of escitalopram tablets before the end of that period. Generic drugs approved by FDA have the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm296006.htm