NEW YORK, Sep 29, 2003 /PRNewswire-FirstCall via COMTEX/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that it has received an approvable letter from the
United States Food and Drug Administration (FDA) to expand the use of
Lexapro(TM) (escitalopram oxalate) to include the treatment of generalized
anxiety disorder (GAD). Lexapro is the newest and most selective serotonin
reuptake inhibitor (SSRI), and is currently indicated for the initial and
maintenance treatment of major depressive disorder. A supplemental New Drug
Application (sNDA), which was based on three placebo-controlled studies in
patients suffering from GAD, was submitted to the FDA in November 2002. The
approvable letter involves resolution of routine matters and therefore Forest
continues to expect to launch Lexapro for GAD in early 2004 subject to final
approval.
About Generalized Anxiety Disorder
Anxiety disorders are the most common mental illness in the U.S.,
affecting 19.1 million adults, and they cost the U.S. more than $42 billion a
year. The prevalence of generalized anxiety disorder (GAD) is estimated to be
4 million or 2.8% of the U.S. population, and it affects women twice as often
as men. According to The Diagnostic and Statistical Manual of Mental
Disorders (DSM-IV-TR), the essential feature of GAD is excessive anxiety and
worry (apprehensive expectations) about every day events or activities for a
period of six months or more. This constant worry affects daily functioning
and can cause physical symptoms. For a diagnosis to be made, worry must be
present more days than not for at least six months. GAD frequently co-occurs
with mood disorders, including depression. Additionally, up to 80% of people
suffering from depression also experience symptoms of anxiety.
About Lexapro
Lexapro is the newest and fastest-growing selective serotonin reuptake
inhibitor (SSRI). Lexapro was developed by isolating the therapeutically
active portion of the antidepressant Celexa(TM) (citalopram HBr).
Lexapro was approved by the U.S. Food and Drug Administration (FDA) in
August 2002 for both the initial and maintenance treatment of major depressive
disorder. Lexapro is available as tablets and oral solution.
As with all SSRIs, Lexapro should not be taken together with monoamine
oxidase inhibitors (MAOI). For more information about Lexapro, please visit
www.lexapro.com.
Forest Laboratories licenses Lexapro from the Danish pharmaceutical firm
H. Lundbeck A/S, which developed escitalopram and citalopram.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro(TM),
indicated for the initial and maintenance treatment of major depressive
disorder; Celexa(TM), an antidepressant; Tiazac(R), a once-daily diltiazem,
indicated for the treatment of angina and hypertension; Benicar(R), an
angiotensin receptor blocker indicated for the treatment of hypertension; and
Aerobid(R), an inhaled steroid indicated for the treatment of asthma.
Except for 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, 2003. Actual results
may differ materially from those projected.