Posted by Michael Wonder on 24 Apr 2018
FDA accepts Veloxis's supplemental new drug application for the de novo indication for Envarsus XR
19 April 2018 - Veloxis Pharmaceuticals announced today that the U.S. FDA has accepted for standard review the Company's supplemental new drug application 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 application was submitted to the FDA on 7 March 2018. FDA has set a target review date under the Prescription Drug User Fee Act of 7 January 2019.
