Astellas' Prograf "Approvable" For Use In Combination With Roche's CellCept
This article was originally published in PharmAsia News
Executive Summary
A supplemental NDA for Astellas' immunosuppressant Prograf (tacrolimus) was deemed "approvable" after FDA expressed concern that tacrolimus in combination with another immunosuppressant could lead to an increase in infection-related mortality, the Japanese pharma announced March 20