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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Dual antibody including HBV-Ab 17, libivirumab, and HBV-Ab 19, exbivirumab
Date Designated: 07/15/2003
Orphan Designation: For the prevention of hepatitis B virus (HBV) reinfection in patients who have received a liver transplantation
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Cubist Pharmaceuticals
65 Hayden Avenue
Lexington, Massachusetts 02421
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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