FDA Accepts NDA for Extended-Release Tacrolimus for Organ Rejection Prophylaxis
Astellas announced that the FDA has accepted for review the company's New Drug Application (NDA) for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients. Tacrolimus extended-release capsules are a once daily formulation of the calcineurin inhibitor immunosuppressant tacrolimus (Prograf; Astellas).
The NDA submission is based on six randomized and comparative studies of 2,842 (1,689 tacrolimus extended-release) kidney transplant recipients and 689 (393 tacrolimus extended-release) liver transplant recipients. Astellas also has more than five years of follow-up patient data from the treatment of transplant recipients with tacrolimus extended-release capsules.
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