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Envarsus XR Approval History

FDA Approved: Yes (First approved July 10, 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 kidney transplant patients.

Development History and FDA Approval Process for Envarsus XR

DateArticle
Dec 19, 2018Approval FDA Approves New Indication for Envarsus XR (tacrolimus extended-release tablets)
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

Further information

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