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
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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After several years of regulatory struggles Sanofi’s anti-arrhythmic Multaq finally got to market. But results from a new study have drawn attention to safety problems in higher-risk patients and could damage the drug’s commercial opportunity.
Company has sent a "Dear Dr." letter describing rare cases of liver problems and will also send additional data to FDA from the clinical trials.