Skip to Content

Zortress Approval History

Zortress (everolimus) is an oral inhibitor of the mTOR pathway indicated for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk.

Development History and FDA Approval Process for Zortress

Apr 22, 2010Approval Novartis Receives US FDA Approval for Zortress (everolimus) to Prevent Organ Rejection in Adult Kidney Transplant Recipients
Nov 16, 2005FDA Advisory Committee Recommends Additional Study Data to Support Approval of Certican in Heart Transplant Recipients
Aug 30, 2004FDA Issues 'Approvable Letter' for Certican

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.