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FDA Issues Non-Approvable Letter for Panic Disorder Indication for Escitalopram Oxalate

NEW YORK, March 1, 2005 /PRNewswire-FirstCall via COMTEX/ -- Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today reported that the U.S. Food and Drug Administration (FDA) has issued a second non-approvable letter for the indication of Panic Disorder for Lexapro(R) (escitalopram oxalate), an SSRI antidepressant. The Company indicated that the letter was pursuant to an FDA review of its response, dated August 2004, to an initial non-approvable letter which raised issues related to methods and statistical analyses performed for the two placebo-controlled trials provided in the submission. The Company is currently reviewing the FDA's response in order to determine the appropriate action regarding the Panic Disorder submission. Both studies included in the submission have been previously published in medical journals. Lexapro is indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults.

Source: Forest Laboratories

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