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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 clinical trials, the most commonly observed adverse events with an incidence of >5% and at least twice that of placebo were nausea, somnolence, asthenia, diarrhea, anorexia, tremor, and sweating. Overall, these side effects were mild to moderate in severity and transient in nature. Other common adverse events with an incidence of >5% and at least twice that of placebo included abnormal ejaculation and anorgasmia.

The use of alosetron, tizanidine, thioridazine, or pimozide with LUVOX CR Capsules is contraindicated. The use of MAO inhibitors in combination with LUVOX CR Capsules or within 14 days of discontinuing treatment with LUVOX CR Capsules is contraindicated. (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS in full prescribing information.) LUVOX CR Capsules are also contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate or any of its excipients.

Clinical Measures

LSAS: A clinician-rated, 24-item scale used to assess the range of difficulties in social interaction (11 questions) and performance situations (13 questions) that a patient with SAD may have.

Y-BOCS: A clinician-rated, 10-item scale used to rate the severity of obsessive compulsive symptoms and to monitor improvement during treatment.

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. Jazz Pharmaceuticals will host an Investor Day on March 13, 2008 beginning at 10:00 a.m. Eastern Time/7:00 a.m. Pacific Time. The event will be available by live audio webcast, and the accompanying presentation materials will also be available on the investor relations section of Jazz Pharmaceuticals' website. For further information, please visit http://www.JazzPharmaceuticals.com.

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SOURCE Jazz Pharmaceuticals, Inc.
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