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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: heterodimeric fusion protein that binds to IL-1 beta consisting of human extracellular domain of IL1 receptor and a mutant Fc fragment of human IgG1 and part of human IL1 receptor accessory protein
Date Designated: 10/15/2018
Orphan Designation: Treatment of Schnitzler Syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
R-Pharm Overseas
505 Cost Boulevard South
Suite #102
San Diego, California 92037
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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