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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: abatacept
Trade Name: Orencia
Date Designated: 12/26/2017
Orphan Designation: Prevention of graft versus host disease
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Co.
P. O. Box 5326
Princeton, New Jersey 08543
United States

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

Marketing approved:

1 Generic Name: abatacept
Trade Name: Orencia
Marketing Approval Date: 12/15/2021
Approved Labeled Indication: prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor
Exclusivity End Date: 12/15/2028 
Exclusivity Protected Indication* :  prophylaxis of acute graft versus host disease (aGVHD) in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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