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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Recombinant Human soluble Fc-gamma Receptor IIb
Date Designated: 03/22/2010
Orphan Designation: Treatment of idiopathic thrombocytopenic purpura
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/27/2019
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Baxalta US Inc., now part of Shire Plc
650 Kendall Street
Cambridge, Massachusetts 02142
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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