FDA Accepts Veloxis`s Supplemental New Drug Application for the De Novo Indication for ENVARSUS XR®
(WorldNews Denmark)

April 19, 2018 Company Release no. 11/2018 To: NASDAQ Copenhagen A/S Copenhagen, Denmark, 19 April 2018 FDA Accepts Veloxis`s Supplemental New Drug Application for the De Novo Indication for ENVARSUS XR® Veloxis Pharmaceuticals A/S announced today 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...