March 14, 2012 -- The FDA approved the first generic version of the popular antidepressant Lexapro (escitalopram) today. Like the brand-name drug, the generic is approved for the treatment of both adult depression and generalized anxiety disorder.
Escitalopram was approved in 2002, and it has been manufactured and marketed by U.S.-based Forest Laboratories Inc., in partnership with the Danish drug company Lundbeck. The generic form will be produced by Teva Pharmaceutical Industries/IVAX Pharmaceuticals, a U.S.-based manufacturer of many common generic medications. The company, which will produce the drug in 5-, 10-, and 20-milligram doses, will be the sole producer of the generic form for six months.
Depression causes ongoing feelings of sadness, anger, and helplessness that can impair a person’s ability to engage in everyday activities, such as working, sleeping, and studying, as well as causing them to lose interest in things they once enjoyed. The CDC estimates that about 9% of adults suffer from some form of depression that lasts two weeks or more. It is twice as common in women as it is in men.
Generalized anxiety disorder (GAD) causes worry, even when there is no reason to worry. While it develops slowly, often beginning in adolescence, it can eventually become severe enough to get in the way of work and other aspects of everyday life. People with GAD often have trouble concentrating and sleeping. Headaches, trembling, and trouble swallowing are also symptoms. The National Institute of Mental Health estimates that about 3% of U.S. adults suffer from GAD in a given year.
"These psychiatric conditions can be disabling and prevent a person from doing everyday activities,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a news release. “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 a selective serotonin reuptake inhibitor (SSRI), a type of antidepressant that works by regulating the chemical messenger serotonin. Common side effects include sleeplessness (insomnia), ejaculation disorder, nausea, increase in sweating, fatigue and drowsiness, and low sex drive (decreased libido).
Like all other antidepressants, escitalopram is packaged with a black box warning regarding an increased risk of suicidal thoughts and behavior among children, adolescents, and young adults when first starting treatment. Those over the age of 24 showed no such risk, and patients 65 and older showed a decreased risk.