US-based pharmaceutical company Forest Laboratories has received the FDA approval of its supplemental new drug application for Lexapro for the acute and maintenance treatment of major depressive disorder in adolescents, 12-17 years of age.
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The approval of Lexapro for the treatment of adolescent depression was supported by two placebo-controlled studies, one conducted in adolescent patients taking Lexapro and one conducted in children and adolescents taking citalopram.
Lexapro is said to be the only second antidepressant to be approved for the treatment of major depressive disorder in adolescents.
Howard Solomon, chairman and CEO, of Forest Laboratories, said: “We have long believed that Lexapro would be of benefit for the treatment of depression in adolescents and that is why we undertook the several studies described in the package insert.
“We are enormously gratified that Lexapro will be available for depressed adolescents who so much require the benefits which Lexapro has made available for depressed adults for the past seven years.”
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