WEDNESDAY, March 14 (HealthDay News) — The Israeli drug maker Teva Pharmaceuticals has gained the first U.S. approval to market generic Lexapro (escitalopram) to treat depression and general anxiety disorder, the U.S. Food and Drug Administration said Wednesday.
Teva was granted 180-day exclusivity, so no other firm can market the generic medication in the United States in that timeframe, the agency said in a news release.
Symptoms of major depression include depressed mood, loss of interest in once pleasurable activities, weight or appetite change, sleep changes, feelings of guilt or worthlessness or thoughts of suicide.
Symptoms of general anxiety disorder include exaggerated worry, always anticipating the worst, inability to relax and difficulty concentrating.
Escitalopram, as with similar antidepressants, has a boxed label warning about increased risk of suicidal thinking, especially among children, teens and young adults. Other potential side effects include changes in sleep pattern, low sex drive, nausea and increased sweating, the FDA said.
Generic drugs have the same high quality and strength as their brand-name predecessors, and must pass the same quality standards, the agency stressed. Brand-name Lexapro, produced by Forest Laboratories, was approved by the FDA in 2002.
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