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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: canakinumab
Trade Name:
Date Designated: 07/31/2017
Orphan Designation: Treatment of adult-onset Still's Disease
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, New Jersey 07936
United States

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

Marketing approved:

1 Generic Name: canakinumab
Trade Name:
Marketing Approval Date: 06/16/2020
Approved Labeled Indication: ILARIS is indicated for the treatment of active Still¿s disease, including Adult-Onset Still¿s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
Exclusivity End Date: 06/16/2027 
Exclusivity Protected Indication* :  For the treatment of active adult-onset Still¿s Disease (AOSD).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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