REMICADE® Receives FDA Approval As First Biologic Treatment For Pediatric Ulcerative

Thread starter tD33NAt
Start date Sep 24, 2011
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approval biologic fda pediatric receives remicadeâ® treatment ulcerative

Sep 24, 2011

tD33NAt

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Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy. This marks the 16th approval of REMICADE® in the U.S. and the seventh for the anti-tumor necrosis factor (TNF)-alpha in the treatment of inflammatory bowel disease (IBD) spanning adult and pediatric Crohn's disease and adult and pediatric UC. It is estimated that 1...