FDA approves Zortress

EAST HANOVER, N.J. The Food and Drug Administration has approved a drug from Novartis for preventing rejection of transplanted organs, the Swiss drug maker said Thursday.

The FDA approved Zortress (everolimus) tablets for preventing rejection of transplanted kidneys in adults as part of a therapy that includes low doses of the immunosuppressant drug cyclosporine, corticosteroids and another Novartis organ transplant drug, Simulect (basiliximab). Zortress is marketed in many foreign countries under the name Certican.

“For patients who require a kidney transplant, the limited availability of organs underscores the urgent need for effective medicines that can help protect the survival of the transplanted organi for the patient,” Novartis Pharmaceuticals division head David Epstein said. “Our commitment to transplant patients exceeds 25 years, and Zortress is the latest addition to our growing portfolio.”