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Non-Approvable Letter Issued for Excitalopram Oxalate in Social Anxiety Disorder
March 31, 2005
NEW YORK, March 30 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE:FRX) announced today that the U.S. Food and Drug Administration (FDA), following its initial review of a supplemental New Drug Application for Lexapro (R) (excitalopram oxalate), an SSRI antidepressant, for the treatment of Social Anxiety Disorder (SAD), has determined the application not approvable. While indicating that data from one of the two required pivotal studies supported the application, the agency raised questions related to the reliability of patient data at one study center in the second pivotal study. Both studies were conducted in Europe. By eliminating the study center in question the statistical significance (p-value) of the study declines to 0.06 which the FDA no longer accepted as a positive pivotal study. Forest is reviewing the FDA's analysis and will determine the appropriate next steps to address the non-approvable letter in the coming months, which may include additional discussions with the FDA pertaining to data from the excluded center or conducting an additional pivotal study. Lexapro is indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults. It is also approved in Europe for Depression, Social Anxiety Disorder and Panic Disorder where it is marketed by H. Lundbeck A/S.
Source: Forest Laboratories, Inc.
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