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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: hepatitis B immune globulin (human)
Trade Name: HepaGam B
Date Designated: 03/24/2008
Orphan Designation: Prevention of hepatitis B recurrence following orthotopic liver transplant
Orphan Designation Status: Designated/Approved
Cangene Corporation
155 Innovation Drive
Winnipeg
Canada

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: hepatitis B immune globulin (human)
Trade Name: HepaGam B
Marketing Approval Date: 04/06/2007
Approved Labeled Indication: Prevention of hepatitis B recurrence following liver transplantation in HBsAG-positive liver transplant patients
Exclusivity End Date: 04/06/2014 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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