FDA approves Astagraf XL (Astellas) for Transplant Rejection
The FDA has approved Astagraf XL (tacrolimus extended-release capsules), from Astellas, for the prophylaxis of organ Transplant Rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction. Approval is based on results from two primary, randomized, comparative Phase III clinical studies which enrolled 1,093 patients (545 on tacrolimus extended-release) in the U.S., Europe, Canada, South America, Australia and South Africa.
Astellas was granted marketing approval for tacrolimus extended-release capsules under the trade name Advagraf in Europe in 2007 and under the trade name Graceptor in Japan in 2008.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins