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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: golimumab
Trade Name: SIMPONI ARIA®
Date Designated: 04/02/2015
Orphan Designation: Treatment of polyarticular juvenile idiopathic arthritis in patients 0 through 18 years of age.
Orphan Designation Status: Designated/Approved
Janssen Research & Development, LLC
1400 McKean Road
Spring House, Pennsylvania 19477
United States

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

Marketing approved:

1 Generic Name: golimumab
Trade Name: SIMPONI ARIA®
Marketing Approval Date: 09/29/2020
Approved Labeled Indication: treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older
Exclusivity End Date: 09/29/2027 
Exclusivity Protected Indication* :  treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 to 18 years of age
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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