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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) Crohn's Disease
Orphan Designation Status: Designated/Approved
Centocor, 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: 05/19/2006
Approved Labeled Indication: For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy
Exclusivity End Date: 05/19/2013 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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