Forest Lexapro launch
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Forest will launch its antidepressant Lexapro (escitalopram) Sept. 5 at a slight discount to parent drug Celexa. FDA cleared the single-isomer follow on to citalopram Aug. 14. Labeling reports greater potency than Celexa in terms of inhibition of 5-HT reuptake, and Forest says the 10 mg recommended starting dose was shown to be comparable to Celexa 40 mg. The firm is highlighting early relief with Lexapro, although labeling does not include onset of action data. The Lexapro NDA was submitted March 23, 2001, and deemed "approvable" Jan. 25. Forest will stop sampling and promotion of Celexa, which loses exclusivity in January 2004 after a six-month pediatric extensio