FDA Accepts Veloxis’s Supplemental New Drug Application for Envarsus XR

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.