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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

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