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

to bloody stools, severe diarrhea and frequent abdominal pain. Tiny open sores, or ulcers, form on the surface of the lining where they bleed and produce pus and mucus. Symptoms of the disease may lead to loss of appetite, subsequent weight loss, and fatigue.  UC is a chronic disease, and there is no cure.  Although progress has been made in inflammatory bowel disease (IBD) research, investigators do not know what causes this disease.

About REMICADE

REMICADE was the first anti-tumor necrosis factor (TNF)-alpha treatment to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology.  REMICADE has demonstrated broad clinical utility with indications in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO).  The safety and efficacy of REMICADE have been well established in clinical trials over the past 17 years and through commercial experience with more than one million patients treated worldwide.

In the U.S., REMICADE is approved for the following indications:

  • Reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA, when administered in combination with methotrexate.  
  • Reducing signs and symptoms in patients with active AS.
  • Reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy.  
  • Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD.  
  • Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal heal
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SOURCE Centocor Ortho Biotech Inc.
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