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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Staphylococcus aureus Immune Globulin (Human)
Date Designated: 01/29/2004
Orphan Designation: Prophylaxis against Staphylococcus aureus infections in low birth weight neonates
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 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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