Ph3,DB/DD,Multi-Ctr,Pros,Rand Study-Efficacy and Safety of LCP-Tacro Tablets, QD, Compared to Prograf Capsules,BID, in Combination With Mycophenolate Mofetil for Acute Allograft Rejection in De Novo Kidney Transplant.
Phase of Trial: Phase III
Latest Information Update: 19 Apr 2018
At a glance
- Drugs Tacrolimus (Primary) ; Tacrolimus
- Indications Renal transplant rejection
- Focus Registrational; Therapeutic Use
- Sponsors Veloxis Pharmaceuticals
- 19 Apr 2018 According to Veloxis Pharmaceuticals media release, the Food & Drug Administration (FDA) has accepted for standard review the Company's supplemental New Drug Application (sNDA) for ENVARSUS XR (tacrolimus extended-release tablets) for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants. The FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of January 7, 2019.
- 07 Mar 2018 According to Veloxis Pharmaceuticals media release company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food & Drug Administration (FDA) seeking a new indication for ENVARSUS XR (tacrolimus extended-release tablets) for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants. The sNDA is based on data from this trial.
- 10 Jul 2015 According to a Veloxis Pharmaceuticals media release, Envarsus XR [tacrolimus extended-release] has been approved by the U.S. FDA for the prevention of kidney transplant rejection in patients who require conversion from other twice-daily tacrolimus products to once-daily Envarsus XR. The approval is based on the review from this and another phase III trial [see CT profile 7004027] as well as several phase II trials.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History