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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: adalimumab
Trade Name: Humira
Date Designated: 03/21/2005
Orphan Designation: Treatment of juvenile rheumatoid arthritis
Orphan Designation Status: Designated/Approved
AbbVie Inc.
1 North Waukegan Road
Bldg. AP-30
North Chicago, Illinois 60064
United States

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

Marketing approved:

1 Generic Name: adalimumab
Trade Name: Humira
Marketing Approval Date: 02/21/2008
Approved Labeled Indication: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older.
Exclusivity End Date: 02/21/2015 
Exclusivity Protected Indication* :  
2 Generic Name: adalimumab
Trade Name: Humira
Marketing Approval Date: 09/30/2014
Approved Labeled Indication: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
Exclusivity End Date: 09/30/2021 
Exclusivity Protected Indication* :  Treatment of polyarticular juvenile idiopathic arthritis in patients 2 to less than 4 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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