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FDA Accepts sNDA for the De Novo Indication for ENVARSUS XR

americanpharmaceuticalreviewApril 23, 2018

Tag: FDA , sNDA

Veloxis announced 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.

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