FDA Approves First Generic for Anti-Depressant Lexapro

The U.S. Food and Drug Administration just approved the first generic version of the popular antidepressant, Lexapro (escitalopram). The generic, just like Lexapro, is approved for use in the treatment of both depression, as well as generalized anxiety disorder.

Depression causes feelings of sadness, anger, loneliness, and helplessness that can severely impair one’s ability to function on a day-to-day basis. Simple tasks such as working, socializing, sleeping, studying, eating, etc., become difficult, if not impossible, for these affected patients. Depression causes them to lose interest in activities they used to enjoy, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and thoughts of suicide. The Centers for Disease Control and Prevention, or the CDC, estimates that about 9 percent of adults suffer from some form of depression, lasting two weeks or more. Depression is twice as common in women than in men.

Generalized anxiety disorder (GAD) causes intense worry, even if there is no reason to worry, as well as tension, even if nothing brought it on. People with GAD are constantly worrying, anticipating the worst in every situation. They are overly concerned about health issues, money issues, family problems, or difficulties at work. A person is diagnosed with GAD when they worry excessively about everyday issues for a period of six months or more.

If left untreated, GAD becomes severe enough to affect work, ability to concentrate, family life, socialization, and sleeping. Symptoms of GAD are sleeplessness, trembling, headaches, dysphagia, and hives. These patients cannot relax. They are easily startled and have great difficulty concentrating. The National Institute of Mental Health estimates that about 3 percent of U.S. adults suffer from GAD annually.

“These psychiatric conditions can be disabling and prevent a person from doing everyday activities,” said Janet Woodstock, 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 milligram, and 20 milligram strengths.

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

It is great that the public finally has an affordable form of this popular antidepressant medication. So many Americans suffer from this debilitating disease and this generic will provide the opportunity for so many people to be able to receive help for their depression.

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