Forest Laboratories, Inc announced that the US Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Lexapro (escitalopram oxalate) for the acute and maintenance treatment of Major Depressive Disorder (MDD) in adolescents, 12 to 17 years of age. Lexapro is only the second antidepressant to be approved for the treatment of MDD in adolescents, a medical condition that affects approximately 2 million adolescents in the US.
"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."
"Adolescent depression can often be challenging to treat because there are limited treatment options that are proven to be effective and well-tolerated in this patient population," said Graham Emslie, professor of Psychiatry at the University of Texas Southwestern Medical Center in Dallas. "The FDA approval of Lexapro for adolescents is a significant development for the patients who struggle with this illness every day."
Lexapro is indicated for the acute and maintenance treatment of MDD in adults and adolescents (aged 12 to 17) and for acute treatment of Generalized Anxiety Disorder (GAD) in adults.