Novartis Certican Short-Term Renal Safety Study Suggested By Panel
Executive Summary
A short-term renal toxicity study establishing the safety of Novartis' Certican with lower doses of cyclosporine could sway members of FDA's Cardiovascular & Renal Drugs Advisory Committee to recommend approval of the immunosuppressant in heart transplantation
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Taking the panel's previous advice to demonstrate everolimus' efficacy with lower doses of cyclosporine is what gained the committee endorsement Dec. 7.