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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: 10/04/2016
Orphan Designation: Prevention of rejection in kidney, liver or heart transplant in pediatric patients
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: 05/24/2018
Approved Labeled Indication: For the prophylaxis of organ rejection, in patients receiving allogeneic kidney transplant, liver transplants and heart transplant, in combination with other immunosuppressants.
Exclusivity End Date: 05/24/2025 
Exclusivity Protected Indication* :  For the prophylaxis of organ rejection in pediatric patients receiving allogeneic kidney transplant and heart transplant, in combination with other immunosuppressants.
2 Generic Name: tacrolimus
Trade Name: Prograf
Marketing Approval Date: 05/24/2018
Approved Labeled Indication: For the prophylaxis of organ rejection, in patients receiving allogeneic kidney transplant, liver transplants and heart transplant, in combination with other immunosuppressants.
Exclusivity End Date: 05/24/2025 
Exclusivity Protected Indication* :  For the prophylaxis of organ rejection in pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants.
3 Generic Name: tacrolimus
Trade Name: Prograf
Marketing Approval Date: 05/24/2018
Approved Labeled Indication: For the prophylaxis of organ rejection, in patients receiving allogeneic kidney transplant, liver transplants and heart transplant, in combination with other immunosuppressants.
Exclusivity End Date: 05/24/2025 
Exclusivity Protected Indication* :  For the prophylaxis of organ rejection in pediatric patients receiving allogeneic kidney transplant and heart transplant, in combination with other immunosuppressants.
4 Generic Name: tacrolimus extended-release capsules
Trade Name: Astagraf XL
Marketing Approval Date: 11/29/2018
Approved Labeled Indication: prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients.
Exclusivity End Date: N/A  
*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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