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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 extended-release capsules
Trade Name:  Astagraf XL
Date Designated:  10/04/2016
Orphan Designation:  Prevention of rejection in kidney, liver or heart transplant in pediatric patients
Orphan Designation Status:  Designated/Approved
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:     
Exclusivity Protected Indication* :  
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.
 
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
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.
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.
 
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
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.
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.
 
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
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.
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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