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Envarsus XR Approval History

  • FDA approved: Yes (First approved July 10th, 2015)
  • Brand name: Envarsus XR
  • Generic name: tacrolimus
  • Dosage form: Extended-Release Tablets
  • Company: Veloxis Pharmaceuticals A/S
  • Treatment for: Organ Transplant, Rejection Prophylaxis

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

Development History and FDA Approval Process 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
Sep  6, 2011Veloxis Pharmaceuticals' Once-Daily LCP-Tacro Meets Non-Inferiority Endpoint When Compared to Twice-Daily Tacrolimus Tablets in Stable Kidney Transplant Patients
Jul 28, 2010Limerick BioPharma Announces Positive Phase 1b Data for LIM-0705 in Preventing Toxicities Associated with the Transplant Drug, Tacrolimus

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