Trial Profile
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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 02 Aug 2022
Price :
$35
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At a glance
- Drugs Tacrolimus (Primary) ; Tacrolimus
- Indications Renal transplant rejection
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Veloxis Pharmaceuticals
- 19 Dec 2018 According to a Veloxis Pharmaceuticals media release, based on the data from this trial of the phase 3 clinical development program, the U.S. FDA has approved a new indication for Envarsus XR (tacrolimus extended-release tablets) to prevent organ rejection in de novo kidney transplant patients in combination with other immunosuppressants.
- 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.