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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

PALO ALTO, Calif., Feb. 28 /PRNewswire-FirstCall/ -- Today, Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has approved Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) in adults. LUVOX CR is a selective serotonin reuptake inhibitor (SSRI) that incorporates Elan's proprietary SODAS(R) (Spheroidal Oral Drug Absorption System) technology designed to minimize peak-to-trough plasma level fluctuations over a 24-hour period.

In clinical trials at the primary endpoint of 12 weeks, Once-A-Day LUVOX CR provided statistically significant improvement vs. placebo in SAD symptoms as measured by the LSAS (Liebowitz Social Anxiety Scale) and statistically significant improvement vs. placebo in OCD symptoms as measured by the Y-BOCS (Yale-Brown Obsessive Compulsive Scale)(1) (2) (3) (4).

"We are pleased to have FDA approval of this new, effective treatment option for patients in the United States with SAD and OCD and our proceeding towards launch by the end of this quarter," said Samuel Saks, M.D., chief executive officer of Jazz Pharmaceuticals. "As part of our commitment to patients with these two serious and widely under-recognized anxiety disorders, we are working with patient advocacy organizations to raise awareness about these conditions and encourage patients to get accurately diagnosed."

"The approval of Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules for social anxiety disorder and obsessive compulsive disorder is important for the 15 million Americans with SAD and the 2.2 million Americans with OCD, two underdiagnosed and undertreated anxiety
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SOURCE Jazz Pharmaceuticals, Inc.
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