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CV Therapeutics’ Pre-"Approvable" Letter To FDA’s Temple

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Excerpts from an Oct. 20, 2003 letter to Office of Drug Evaluation I Director Robert Temple. CV Therapeutics CEO Robert Lange and VP-Clinical R&D Andrew Wolff proposed a risk management program (ultimately not instituted upon approval) and downplayed QT concerns regarding Ranexa. FDA issued an "approvable" letter ten days later.

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