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Forest Lexapro Approval Includes Label Claim Of Greater Potency Than Celexa

Executive Summary

Forest's Lexapro (escitalopram) label includes a statement of greater potency than its predecessor antidepressant Celexa (citalopram)

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Forest Lexapro maintenance claim

Forest Lexapro receives supplemental approval for prevention of relapse following long-term treatment of major depressive disorder Aug. 29. Escitalopram longer-term efficacy data will replace data from the predecessor antidepressant Celexa (citalopram) in Lexapro's Aug. 14 approved labeling (1"The Pink Sheet" Aug. 19, p. 3). The sNDA was filed Oct. 29, seven months after the NDA was filed...

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