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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: anakinra
Trade Name: Kineret
Date Designated: 08/19/2010
Orphan Designation: Treatment of cryopyrin-associated periodic syndromes
Orphan Designation Status: Designated/Approved
Swedish Orphan Biovitrum AB (publ)
SE-011276
Stockholm
Sweden

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

Marketing approved:

1 Generic Name: anakinra
Trade Name: Kineret
Marketing Approval Date: 12/21/2012
Approved Labeled Indication: Treatment of neonatal-onset multisystem inflammatory disease (NOMID)
Exclusivity End Date: 12/21/2019 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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