The US Food and Drug Administration has again rejected Forest Laboratories’ bid to market its Lexapro (escitalopram) antidepressant as a treatment for panic disorder, and issued a second non-approvable letter to the US company.
Forest initially filed Lexapro with the FDA back in April 2003 in the treatment of panic disorder [[02/05/03d]]. However, it was knocked back in February last year after the agency questioned the drug’s efficacy in this new indication as a result of the methods and statistical analyses performed for two placebo-controlled trials included in the submission. The company believed that its response to the FDA addressed all the issues. Forest says it is now reviewing the FDA’s second non-approvable letter in order to determine the future course of action for the panic disorder submission.
Lexapro is indicated for the initial and maintenance treatment of major depressive disorder [[23/08/02d]], and for generalised anxiety disorder in adults [[19/12/03e]]. It generated third quarter 2004 sales of some $427 million dollars [[19/01/05d]].
