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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: infliximab
Trade Name: Remicade
Date Designated: 11/12/2003
Orphan Designation: Treatment of pediatric (0 to 16 years of age) ulcerative colitis
Orphan Designation Status: Designated/Approved
Janssen Biotech, Inc.
200 Great Valley Parkway
Malvern, Pennsylvania 19355
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: infliximab
Trade Name: Remicade
Marketing Approval Date: 09/23/2011
Approved Labeled Indication: For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy
Exclusivity End Date: 09/23/2018 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.