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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Immune Globulin Subcutaneous (Human)
Date Designated: 09/22/2004
Orphan Designation: Treatment of patients with primary immune deficiency (PID) that are intolerant to immune globulin intravenous (IGIV) due to severe adverse events or poor venous access
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CSL Behring
1020 First Avenue
P.O. Box 61501
King of Prussia, Pennsylvania 19406
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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