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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
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
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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