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From the Food and Drug Administration
October 7, 1998

Crohn's Disease Treatment Approved

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Copyright 1998 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1998American Medical Association

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JAMA. 1998;280(13):1128. doi:10.1001/jama.280.13.1128

The manufacturer of Infliximab (Remicade, Centocor, Malvern, Pa) has received "accelerated approval" for treatment of Crohn's disease after demonstrating significant short-term benefits for the treatment of this serious gastrointestinal disease, and after agreeing to further studies of the effects of chronic therapy. The product is manufactured using cells containing human and mouse antibody genes. The product is indicated for treatment of moderately to severely active Crohn's disease, for the reduction of signs and symptoms in patients who have an inadequate response to conventional therapy, and for the treatment of draining enterocutaneous fistula(s) in patients with fistulizing Crohn's disease.

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