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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

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In January 2007, Jazz Pharmaceuticals licensed the right to market Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules in the U.S. from Solvay Pharmaceuticals. The license agreement provides for Jazz Pharmaceuticals to pay Solvay Pharmaceuticals $20 million as a result of the approval of LUVOX CR for both SAD and OCD and the approved expiry dating of the product.

The approval of LUVOX CR includes a post marketing commitment to conduct a safety and efficacy study in adolescent patients with SAD and a long-term safety and efficacy study in patients with SAD. The NDA for LUVOX CR is being transferred to Jazz Pharmaceuticals.

For more information about LUVOX CR, please visit http://www.JazzPharmaceuticals.com

Social Anxiety Disorder

SAD or social phobia is characterized by the fear and avoidance of social or performance situations where patients feel that others may scrutinize them and they may embarrass themselves. Patients experience physical symptoms of anxiety, including blushing, sweating, trembling and nausea. (5) SAD affects an estimated 15 million American adults. (6)

Obsessive Compulsive Disorder

OCD is a chronic and debilitating anxiety disorder that is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions) that are severe enough to cause significant impairment. Patients are compelled to perform repetitive behaviors such as hand washing, counting, checking or cleaning with the goal of preventing obsessive thoughts or making them go away.5 OCD affects approximately 2.2 million American adults.6

Important Safety Information

Antidepressants can increase suicidal thoughts and behaviors in children, adolescents and young adults. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. '/>"/>

SOURCE Jazz Pharmaceuticals, Inc.
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