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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tacrolimus
Trade Name: Prograf
Date Designated: 09/12/2019
Orphan Designation: Prevention of rejection in lung transplantation
Orphan Designation Status: Designated/Approved
Astellas Pharma Global Development, Inc.
1 Astellas Way
Northbrook, Illinois 60062
United States

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

Marketing approved:

1 Generic Name: tacrolimus
Trade Name: Prograf
Marketing Approval Date: 07/16/2021
Approved Labeled Indication: Prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic kidney transplant, liver transplant, heart transplant, or lung transplant in combination with other immunosuppressants
Exclusivity End Date: 07/16/2028 
Exclusivity Protected Indication* :  Prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic lung transplant
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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