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FDA Approves Luvox(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
Date:2/28/2008

disorders," said John H. Greist, M.D., distinguished senior scientist, Madison Institute of Medicine and clinical professor of psychiatry, University of Wisconsin Medical School. "Physicians have been using immediate-release fluvoxamine for years to treat OCD patients. Now having Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules offers patients with SAD and OCD an additional option."

The FDA evaluated a data package involving approximately 600 patients worldwide that included three clinical trials with positive outcomes evaluating the efficacy and safety of LUVOX CR. These studies were:

Social Anxiety Disorder

-- Davidson, Jonathan, et al. Fluvoxamine-controlled release formulation

for the treatment of generalized social anxiety disorder. J Clin

Psychopharmacol 2004; 24:118-125.

-- Westenberg, Herman, et al. A double-blind, placebo-controlled study of

controlled-release fluvoxamine for the treatment of generalized social

anxiety disorder. J Clin Psychopharmacol. 2004; 24:49-55.

Obsessive Compulsive Disorder

-- Hollander, Eric, et al. A double-blind, placebo-controlled study of

the efficacy and safety of controlled-release fluvoxamine in patients

with obsessive-compulsive disorder. J Clin Psychiatry. 2003;

64:640-647.

"SAD and OCD are serious, yet treatable conditions," said Jerilyn Ross, M.A., L.I.C.S.W., president and CEO, Anxiety Disorders Association of America (ADAA). "We're excited about new treatment options -- both medications and psychological -- to help patients with these chronic and undertreated anxiety disorders. Having treatment options benefits the patient, and that's what is most important."

LUVOX CR will be available in 100 mg and 150 mg dose strengths. Over the next several weeks, Jazz Pharmaceuticals will continue to work closely with Elan on the manufacturing of LUVOX CR for commercial launch. '/>"/>

SOURCE Jazz Pharmaceuticals, Inc.
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