FDA Approves LUVOX(R) CR Extended-Release Capsules For The Treatment Of Social Anxiety Disorder (SAD) And Obsessive Compulsive Disorder (OCD)

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FDA Approves LUVOX(R) CR Extended-Release Capsules For The Treatment Of Social Anxiety Disorder (SAD) And Obsessive Compulsive Disorder (OCD)

(March 03, 2008) -- Solvay Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LUVOX® CR (fluvoxamine maleate) Extended-Release Capsules for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) in adults.

In January 2007, Solvay Pharmaceuticals licensed the right to market LUVOX CR (fluvoxamine maleate) Extended-Release Capsules and LUVOX (fluvoxamine maleate) Immediate-Release Tablets to Jazz Pharmaceuticals in the United States. The license agreement provides for Jazz Pharmaceuticals to pay Solvay Pharmaceuticals $20 million as a result of the approval of LUVOX CR. In addition, Solvay Pharmaceuticals will transfer ownership of the New Drug Application for LUVOX CR to Jazz Pharmaceuticals.

"The FDA approval of LUVOX CR marks an important milestone in the relationship between Jazz Pharmaceuticals and Solvay Pharmaceuticals," said Laurence J. Downey, M.D., president and CEO of Solvay Pharmaceuticals, Inc. "We are confident that Jazz Pharmaceuticals will successfully bring this important treatment option to patients in the United States."

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

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.

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% included abnormal ejaculation and anorgasmia.

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LUVOX CR Capsules are contraindicated in patients taking alosetron, tizanidine, thioridazine, or pimozide. 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 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.

Source: Medical News Today

Last updated: 03/08

FDA Approves LUVOX(R) CR Extended-Release Capsules For The Treatment Of Social Anxiety Disorder (SAD) And Obsessive Compulsive Disorder (OCD)

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