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US FDA Approves Generic Lexapro for Adult Depression, Anxiety Disorder

by Dr. Trupti Shirole on March 15, 2012 at 11:29 PM
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 US FDA Approves Generic Lexapro for Adult Depression, Anxiety Disorder

The U.S. Food and Drug Administration (US FDA) has approved the first generic Lexapro tablets (escitalopram) to treat depression and anxiety disorder in adults. The drug will be marketed by Teva Pharmaceutical Industries/IVAX Pharmaceuticals in 5 mg, 10 mg and 20 mg strengths.

Escitalopram is a selective serotonin reuptake inhibitor (SSRI). It is a type of antidepressant that works by regulating the chemical messenger serotonin. Some adverse reactions like sleeplessness (insomnia), ejaculation disorder, nausea, increase in sweating, fatigue and drowsiness and low sex drive (decreased libido) were observed during clinical trials.

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Director of the FDA's Center for Drug Evaluation and Research, Janet Woodcock said, "This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options."

Escitalopram is packaged with a black box warning regarding an increased risk of suicidal thoughts and behavior among children, adolescents and young adults aged 18-24 years when first starting treatment. Those over the age of 24-years showed no such risk, and patients 65-years and older showed a decreased risk.

Source: Medindia
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