Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

December 9, 2003

Briefing Information

Action Letter to CV Therapeutics, Inc., FDA (PDF)

Divisional Memorandum, October 28, 2003, FDA (HTM) (PDF) (Word)

Group Leader Menorandum - Amendment to the Secondary Review (PDF)

Group Leader Memorandum, Secondary Review (PDF)

Clinical Review, FDA (PDF)

Medical Review of Safety (HTM) (PDF) (Word)

Integrated Summary of Efficacy: Ranolazine (PDF)

Addendum to Efficacy Review for Ranolazine (PDF)

Memorandum Regarding Nonclinical Electrophysiological Effects of Ranolazine, October 23, 2003, FDA (HTM) (PDF) (Word)

Overview of Pre-clinical Reproductive Toxicology Studies of Ranolazine, FDA (PDF)

Pharmacology Memorandum to File, November 29, 2003, FDA (HTM) (PDF) (Word)

Memorandum Regarding Nonclinical Electrophysiological and Proarrhythmic Effects of Ranolazine, FDA (HTM) (PDF) (Word)

Pharmacology/Toxicology Review, FDA

FDA Background - Biopharmaceutical Reviews (PDF)


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.

Briefing Document - Ranexa™ (ranolazine) Extended Release Tablets, CV Therapeutics (PDF)