U.S. Food and Drug Administration

Novartis Receives US FDA Approval for Zortress (everolimus) to

Published in Medical Letter on the CDC and FDA, May 9th, 2010

The US Food and Drug Administration (FDA) has approved Zortress=AE (everolimus) oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk. Zortress is to be given in combination with reduced doses of the calcineurin inhibitor (CNI) cyclosporine, as well as basiliximab and corticosteroids.

Under the brand name Certican=AE, everolimus is already an established part of the immunosuppressive regimen for transplant patients in more than 70 countries outside the US.

"For patients who require a kidney transplant, the limited availability of organs underscores the urgent need for effective...

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Source: Medical Letter on the CDC and FDA (2010-05-09)

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