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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Monoclonal antibody to hepatitis B virus (human)
Date Designated: 06/17/1991
Orphan Designation: Prophylaxis of hepatitis B reinfection in patients undergoing liver transplantation secondary to end-stage chronic hepatitis B infection.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Protein Design Labs, Inc.
34801 Campus Dr.
Fremont, California 94555
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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