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Sanofi-Aventis plans Multaq NDA resubmission in 2008

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA issued a "not approvable" letter for Sanofi-Aventis' Multaq (dronedarone) for treatment of atrial fibrillation/atrial flutter on Aug. 31. The company says it will resubmit the NDA in 2008 to include data from the ongoing ATHENA trial. Sanofi recently expanded the ATHENA sample size from 3,700 to 4,300 patients to attain the planned event rates. The dronedarone NDA was submitted in June 2005 based on the EURIDIS and ADONIS trials (1Pharmaceutical Approvals Monthly December 2005, p. 10)...
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