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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Daclizumab
Trade Name: Zenapax
Date Designated: 03/05/1993
Orphan Designation: Prevention of acute renal allograft rejection.
Orphan Designation Status: Designated/Approved
Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley, New Jersey 07110
United States

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

Marketing approved:

1 Generic Name: Daclizumab
Trade Name: Zenapax
Marketing Approval Date: 12/10/1997
Approved Labeled Indication: Prophylaxis of acute organ rejection in patients receiving renal transplants, to be used as a part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.
Exclusivity End Date: 12/10/2004 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.