FDA has now approved tacrolimus for de novo use in kidney transplantation. This approval is based on the results of a randomized, double-blind, double-dummy trial that included 543 de novo kidney transplant patients. The US Food & Drug Administration (FDA) has approved a new indication for tacrolimus extended-release (ER) tablets to prevent organ rejection in de novo kidney transplant patients in combination with other immunosuppressants. This indication is commonly known as “the de novo indication” .
Tacrolimus ER has earlier been approved by the US FDA for the prophylaxis of organ rejection in kidney transplant patients in 2015. This has led to the use of Tacrolimus ER by more than 90% in various transplant centers across the US. The recent approval of de novo use of tacrolimus ER provides an important new treatment option for kidney transplant patients and providers. This…
