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Centocor Ortho Biotech Inc. Submits Application to FDA Seeking to Expand SIMPONI® Label to Include Inhibition of Structural Damage in Treatment of Psoriatic Arthritis
Date:11/11/2010

0;For additional information on psoriatic arthritis, visit the National Psoriasis Foundation.

About SIMPONI

SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. A once-monthly subcutaneous anti-TNF-alpha therapy with marketing authorizations in the Unites States, Europe and Canada, SIMPONI is approved for the treatment of moderately to severely active RA in combination with methotrexate, active PsA and active AS.  SIMPONI is available either through the SIMPONI SmartJect® autoinjector or a prefilled syringe.  For more information about SIMPONI, visit www.SIMPONI.com.  

Centocor Ortho Biotech Inc. discovered and developed SIMPONI and has exclusive marketing rights to the product in the United States.

Important Safety Information

SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

You should not start SIMPONI® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have
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SOURCE Centocor Ortho Biotech Inc.
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