FDA Approves Remicade to Treat Children With Ulcerative Colitis

The Food and Drug Administration Sept. 23 approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than six years who have had inadequate responses to conventional therapy.

Remicade reduces the signs and symptoms of UC and induces and maintains clinical remission in these patients, FDA said. UC is a type of inflammatory bowel disease (IBD) that affects the lining of the large intestine (colon) and rectum. Symptoms of UC include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever, the agency said. Remicade is manufactured by Malvern, Pa.-based Janssen Biotech Inc., a subsidiary of ...