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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Staphylococcal immunoglobulin (human)
Date Designated: 06/13/2001
Orphan Designation: Reduction (prevention) of nosocomial bacteremia caused by staphylococci in very low birth weight infants.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Inhibitex, Inc.
8995 Westside Parkway
Suite 150
Alpharetta, Georgia 30004
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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