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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: interleukin-1 receptor antagonist (IL-1Ra, sequence-homologous anakinra)
Date Designated: 08/07/2018
Orphan Designation: Treatment of Bronchiolitis Obliterans
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Onspira Therapeutics, Inc., a wholly owned subsidiary of Sumitomo Pharma America, Inc.
101 Lindenwood Drive
Suite 400
Malvern, Pennsylvania 19355
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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