Lexapro "not approvable" for social anxiety
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's March 25 "not approvable" letter for Forest's Lexapro (escitalopram) social anxiety disorder sNDA questions the reliability of data from a single study center, the company says. Excluding the problem center from efficacy analyses yields a non-statistically significant p-value of 0.06, "which the FDA no longer accepted as a positive pivotal study," Forest says. The decision closely follows FDA's second "not approvable" letter for use of the Celexa (citalopram) follow-on in panic disorder (1Pharmaceutical Approvals Monthly March 2005, In Brief)...
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