Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

November 16, 2005

The committee will discuss new drug application (NDA) 21-628, proposed trade name Certican® (everolimus) Tablets

 (0.25 mg, 0.50 mg, 0.75 mg and 1.0 mg), Novartis Pharmaceuticals Corporation, for the proposed indication of

 prophylaxis of rejection in heart transplantation.

Briefing Information

Novartis Pharmaceutical Corporation


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Novartis Background Material for Certican®

Appendix 1

Appendix 2




Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552).
 These redacted portions will appear as white space on the screen or on the printed page.

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