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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: belatacept
Trade Name: Nulojix
Date Designated: 02/20/2008
Orphan Designation: Prophylaxis of organ rejection in renal allograft recipients
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Company
P. O. Box 4000
Princeton, New Jersey 08543
United States

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

Marketing approved:

1 Generic Name: belatacept
Trade Name: Nulojix
Marketing Approval Date: 06/15/2011
Approved Labeled Indication: Prophylaxis of organ rejection in adult patients receiving kidney transplants
Exclusivity End Date: 06/15/2018 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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