Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: canakinumab
Trade Name: ILARIS
Date Designated: 09/30/2008
Orphan Designation: Treatment of pediatric (age 16 and under) juvenile rheumatoid arthritis.
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza
Bldg 135-566G
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: ILARIS
Marketing Approval Date: 05/09/2013
Approved Labeled Indication: Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
Exclusivity End Date: 05/09/2020 
Exclusivity Protected Indication* :  Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 through 16 years.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-