Search Orphan Drug Designations and Approvals
-
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Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |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 |
Sponsor: |
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. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-