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.