Sometimes It Takes Two NDAs For One Approval: Multaq Odyssey Shows FDA In Search Of Reassurance In Tricky Antiarrhythmic Field
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA approval of Sanofi-Aventis’ Multaq (dronedarone) ultimately required six major clinical trials, four years, two NDAs – one with standard review designation, one with priority – and four separate claims proposed for the indication.
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