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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: Ilaris
Date Designated: 12/18/2007
Orphan Designation: Treatment of cryopyrin-associated periodic syndromes
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: Ilaris
Marketing Approval Date: 06/17/2009
Approved Labeled Indication: Treatment of cryopyrin-associated periodic syndromes (CAPS), in adults and children 4 years of age and older.
Exclusivity End Date: 06/17/2016 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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