The U.S. Food and Drug Administration today approved the first generic
Lexapro (
escitalopram tablets) to treat both
depression and generalized
anxiety disorder in adults.
Depression is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person's lifetime.
Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide.
People with generalized anxiety disorder (GAD) are filled with exaggerated worry and tension, even though there is little or nothing to provoke it. They anticipate disaster and are overly concerned about health issues, money, family problems, or difficulties at work. GAD is diagnosed when a person worries excessively about a variety of everyday problems for at least six months. People with GAD can't relax, startle easily, and have difficulty concentrating.
"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).