Astellas announced it has submitted a New Drug Application (NDA) to the FDA seeking approval for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.
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 conducted in the U.S., Canada, Europe, Australia, Brazil, New Zealand, among other sites. Astellas also has more than five years of follow-up patient data from the treatment of transplant recipients with tacrolimus extended-release capsules.
Tacrolimus extended-release capsules are a once daily formulation of calcineurin-inhibitor immunosuppressant tacrolimus (Prograf; Astellas).
For more information call (800) 727-7003 or visit www.us.astellas.com.