Zortress Reviewed Amidst Changing Expectations For Nephrotoxicity With Renal Transplants
This article was originally published in Pharmaceutical Approvals Monthly
As FDA was reviewing everolimus in 2003, that April the agency approved a Rapamune regimen in which therapeutic drug monitoring was used to adjust sirolimus doses and cyclosporine was reduced or eliminated after two to four months. Pfizer provided two clinical studies to support the new dosing system for sirolimus with cyclosporine ("Rapamune Cyclosporine-Sparing Regimen In Subpopulations Is Cmte. Review Issue," "The Pink Sheet," Jan. 24, 2002).
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