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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Hepatitis B immune globulin intravenous (human)
Date Designated:  03/08/1995
Orphan Designation:  Prophylaxis against hepatitis B virus reinfection in liver transplant patients.
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Biotest Pharmaceuticals Corporation
5800 Park of Commerce Blvd., NW
Boca Raton, Florida 33487
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.