Lexapro "not approvable" again
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Forest has not yet decided on a course of action following a second "not approvable" letter for use of Lexapro (escitalopram) in panic disorder, but is not planning to conduct additional studies at this time, the firm says March 1. FDA's initial "not approvable" letter in February 2004 "raised issues related to methods and statistical analyses performed for the two placebo-controlled studies provided in the submission," the firm said. Forest's separate sNDA for social anxiety disorder has a user fee date of March 25...
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