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US FDA misses Multaq user fee date
01 May 2009
Sue Sutter

sue.sutter@informa.com

US FDA review of labelling and a risk evaluation and mitigation strategy (REMS) for Sanofi-Aventis's Multaq (dronedarone) has delayed regulatory action on the atrial fibrillation drug beyond the user fee date.

The April 30th user fee deadline passed without an approval or complete response...



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