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Biopharmaceuticals FDA

 News Release - February 28, 2008

FDA Approves LUVOX(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)

Approval Prompts Milestone Payment to Solvay Pharmaceuticals

MARIETTA, Ga.--(HSMN NewsFeed)--Today, 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 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.

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.

About Solvay Pharmaceuticals, Inc.

Solvay Pharmaceuticals, Inc., of Marietta, Georgia is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit www.solvaypharmaceuticals-us.com.

Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, gastroenterology, and men’s and women’s health. Its 2007 sales were EUR 2.6 billion and it employs more than 9,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.

SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs more than 28,000 people in 50 countries. In 2007, its consolidated sales amounted to EUR 9.6 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay (NYSE Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the NYSE Euronext stock exchange in Brussels. Details are available at www.solvay.com.


Source: Solvay Pharmaceuticals

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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