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Zortress Approval History

FDA Approved: Yes (First approved April 22, 2010)
Brand name: Zortress
Generic name: everolimus
Dosage form: Tablets
Previous Name: Certican
Company: Novartis Pharmaceuticals Corporation
Treatment for: Organ Transplant, Rejection Prophylaxis

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

DateArticle
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

Further information

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