FDA Rejects Forest Request for New Lexapro Indication

For the second time in a year, the FDA has rejected a request from Forest Laboratories to expand the indication for its antidepressant Lexapro.

Forest has been trying to gain approval for Lexapro (escitalopram oxalate) to be used as a treatment for panic disorder, but the FDA issued the company a nonapprovable letter rejecting the proposed indication. The agency stated that the request was denied because of "issues related to methods and statistical analyses performed for the two placebo-controlled trials provided in the submission."

Lexapro was previously deemed nonapprovable for the panic disorder indication in February 2004.

Forest said it has not decided how it will proceed on the matter. "The company is currently reviewing the FDA's response in order to determine the appropriate action regarding the panic disorder submission," Forest said.

Lexapro is currently indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults.