Skip to Content

Envarsus XR Approval History

Envarsus XR (tacrolimus) is a once-daily extended-release immunosuppressant for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants.

FDA Approval History for Envarsus XR

Jul 10, 2015Approval FDA Approves Envarsus XR (tacrolimus) for Prevention of Organ Rejection in Kidney Transplant Patients
Oct 31, 2014Veloxis Announces Tentative Approval of Envarsus XR
Mar 13, 2014FDA Accepts NDA for Envarsus for the Prevention of Organ Rejection in Kidney Transplant Patients
Dec 30, 2013Veloxis Pharmaceuticals Announces NDA Submission for Envarsus in Kidney Transplant Recipients

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.