Veloxis Pharmaceuticals A/S (CPH:VELO), a commercial-stage specialty pharmaceutical company committed to improving the lives of transplant patients, announced on Thursday the acceptance for standard review by the US Food & Drug Administration (FDA) of the company's supplemental New Drug Application (sNDA) for ENVARSUS XR.
This sNDA 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. This sNDA was submitted to the FDA on 7 March 2018.
Reportedly, US FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of 7 January 2019.
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