Forest Laboratories, Inc. Receives Non-Approvable Letter for Social Anxiety Disorder Indication for Lexapro(R)
March 30 2005 - 5:10PM
PR Newswire (US)
Forest Laboratories, Inc. Receives Non-Approvable Letter for Social
Anxiety Disorder Indication for Lexapro(R) 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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) Except
for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
are subject to risks and uncertainties that affect our business,
including risk factors listed from time to time in the Company's
SEC reports, including the Company's Annual Report on Form 10-K for
the fiscal year ended March 31, 2004, and on form 10-Q for the
periods ended June 30, 2004, September 30, 2004 and December 31,
2004. Actual results may differ materially from those projected.
Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
DATASOURCE: Forest Laboratories, Inc. CONTACT: Charles E. Trian,
Vice President, Investor Relations of Forest Laboratories Inc.,
+1-212-224-6714, Web site: http://www.frx.com/
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