Food and Drug Administration

Cardiovascular and Renal Drugs ADvisory Committee

February 24, 2005

Briefing Information

Food and Drug Administration

Cover Page (HTM) (PDF) (Word)

Table of Contents (HTM) (Word)

Tab 1. [Draft] Questions to the Committee (HTM) (PDF) (Word)

Tab 2. NDA 20-838/S-022 CHARM-Added (Clinical Review) (HTM) (PDF) (Word)

Tab 3. NDA 20-838/S-022 CHARM-Added (Statistical Review) (HTM) (PDF) (Word)

Tab 4. NDA 20-838/S-024 CHARM-Alternative (Clinical Review) (HTM) (PDF) (Word)

Tab 5. NDA 20-838/S-025 CHARM-Preserved (Clinical Review) (HTM) (PDF) (Word)

Tab 6. NDA 02-838/S-022, S-024, S-025 (Statistical Review) (HTM) (PDF) (Word)

AstraZeneca

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.

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