• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
 
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
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:     
Exclusivity Protected Indication* :  
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.
 
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
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
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-