Teva, IVAX receive FDA approval for generic Lexapro to treat depression and GAD

Mar 27 2012

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). 

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.