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.
More information
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