Veloxis Pharmaceuticals A/S announced on 4/19/18 that the U.S. Food & Drug Administration (FDA) has accepted for standard review the Company’s supplemental New Drug Application (sNDA) which seeks 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.  This indication is commonly referred to as the de novo indication.  As previously announced, the sNDA was submitted to the FDA on March 7, 2018.  FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of January 7, 2019.

Envarsus XR is indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants.