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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: Envarsus XR
Date Designated: 12/20/2013
Orphan Designation: Prophylaxis of organ rejection in patients receiving allogeneic kidney transplant
Orphan Designation Status: Designated/Approved
Veloxis Pharmaceuticals, Inc.
1001 Winstead Drive
Suite 310
Cary, North Carolina 27513
United States

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

Marketing approved:

1 Generic Name: tacrolimus
Trade Name: Envarsus XR
Marketing Approval Date: 07/10/2015
Approved Labeled Indication: Prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants
Exclusivity End Date: 07/10/2022 
Exclusivity Protected Indication* :  Prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants
2 Generic Name: tacrolimus
Trade Name: Envarsus XR
Marketing Approval Date: 12/19/2018
Approved Labeled Indication: ENVARSUS XR is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants.
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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