Forest Gains Lexapro Approval in Adolescents

Forest Laboratories received approval from the FDA for its sNDA for Lexapro for the acute and maintenance treatment of Major Depressive Disorder (MDD) in adolescents, ages 12 to 17. Lexapro is the second antidepressant to be approved for the treatment of MDD in adolescents.

The approval was supported by two placebo-controlled studies, one conducted in adolescent patients taking Lexapro and one conducted in children and adolescents taking citalopram. In an eight-week study that compared Lexapro 10-20 mg/day to placebo, patients showed statistically significant improvement from baseline, compared to placebo, on the Children’s Depression Rating Scale-Revised (CDRS-R).

“Major depressive disorder in adolescents is a debilitating, but treatable illness,” said Howard Solomon, chairman and chief executive officer of Forest. “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.”