Forest Laboratories has indicated that the letter came after an FDA review of the company’s response, dated August 2004, to an initial non-approvable letter. The first letter raised issues related to methods and statistical analyses performed for two placebo-controlled trials provided in the submission.
Lexapro (escitalopram oxalate) is a selective serotonin reuptake inhibitor (SSRI) antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults.
Forest Laboratories is currently reviewing the FDA’s response in order to determine the appropriate action regarding the panic disorder submission.
Although this second letter will delay further regulatory action relating to this indication, the news has not had an adverse effect on the company’s shares, which have, in fact, seen a slight increase following word of these developments.