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.
(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.
SOURCE Forest Laboratories, Inc.
Charles E. Triano, Vice President - Investor Relations of Forest Laboratories, Inc.,
+1-212-224-6714, charles.triano@frx.com
http://www.prnewswire.com