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Novartis Certican review

Executive Summary

FDA's Cardiovascular & Renal Drugs Advisory Committee will review Novartis' Certican for prophylaxis of rejection in heart transplantation at a Nov. 16 meeting. Novartis has received two approvable letters for the everolimus NDA (21-628) for 0.25 mg, 0.5 mg, 0.75 mg and 1 mg tablets. The last approvable letter in August 2004 requested more study on use of Certican with lower doses of cyclosporine (1"The Pink Sheet" Sept. 6, 2004, In Brief). The meeting will be held at the CDER advisory committee conference room at 5630 Fishers Lane in Rockville, Md. beginning at 8 a.m. [Editor's Note: To 2watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...

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