Consumer Drug Report
FDA approves first generic Lexapro

Yesterday, the Food and Drug Administration approved the first generic Lexapro (escitalopram tablets) to treat depression and generalized anxiety disorder (GAD) in adults. Teva Pharmaceutical Industries/IVAX Pharmaceuticals has been granted a 180-day period of generic drug exclusivity that prevents the FDA from approving other generic escitalopram tablets during that time.

Depression affects a person’s quality of life. Major symptoms include restlessness, significant weight fluctuation, loss of interest in normal activities, impaired concentration, increased fatigue, low self-esteem, and thoughts of suicide or suicide attempts.

People with GAD tend to have exaggerated feelings of worry or tension, have trouble relaxing or concentrating, and are startled easily. They are also overly concerned with issues of health, money, family, and work. Physicians diagnose GAD when these feelings persist for at least six months.

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

Teva is approved to market escitalopram in 5 milligram, 10 mg, and 20 mg strengths. During a clinical trial for Lexapro, researchers found the most common adverse side effects were insomnia, nausea, ejaculation disorder, low sex drive, increase in sweating, and drowsiness. Escitalopram is included in a class of antidepressants called selective serotonin reuptake inhibitor (SSRI), which work by regulating serotonin, a chemical messenger.

Generic drugs must maintain the same high quality and strength as counterpart brand name drugs. Likewise, manufacturing and packaging of generic drugs must meet the same quality requirements set by the FDA as for brand name drugs. With that in mind, the new generic Lexapro bears a warning label and provides a medication guide with information about the increased risk of suicidal thinking and behavior during initial treatment in children, adolescents, and young adults ages 18 to 24. There is no information about these risks in adults over the age of 24, and people age 65 and older face a decreased risk.


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