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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: 11/14/1995
Orphan Designation: Treatment of 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: 08/24/1998
Approved Labeled Indication: Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms, in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s).
Exclusivity End Date: 08/24/2005 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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