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Centocor Ortho Biotech Inc. Submits Application to FDA Seeking REMICADE® Pediatric Ulcerative Colitis Indication
Date:12/29/2010

ing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy.
  • Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with PsA.  
  • Treatment of adult patients with chronic severe plaque PsO who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

    • REMICADE is unique among available anti-TNF biologic therapies.  It is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting.  REMICADE is a two-hour infusion administered every 4 or 8 weeks (indication-dependent), following a standard induction regimen that requires treatment at weeks 0, 2 and 6.  As a result, REMICADE patients may require as few as six treatments each year as maintenance therapy.

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

    Important Safety Information  

    Only a doctor can recommend a course of treatment after checking a patient's health condition. REMICADE® (infliximab) can cause serious side effects such as lowering your ability to fight infections. There are reports of serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE®.

    Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE® and azathioprine or 6-mercaptopurine.
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    SOURCE Centocor Ortho Biotech Inc.
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