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U.S. FDA approves Remicade to treat ulcerative colitis

Published in Medical Letter on the CDC and FDA, October 30th, 2005

Centocor, Inc., announced that Remicade (infliximab) has been approved by the U.S. Food & Drug Administration (FDA) for the treatment of ulcerative colitis (UC), making Remicade the first and only biologic approved for UC, a chronic inflammatory bowel disease (IBD), according to the company.

Remicade is now indicated for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy.

"The approval of Remicade for the treatment of UC represents a major breakthrough for patients suffering from...

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