Food and Drug Administration
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
Disclaimer
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®
FDA
Disclaimer
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.