Poor Sanofi-Aventis.
They have just received a non-approvable letter from the FDA for dronedarone, a heart drug (for atrial fibrillation) aka Multaq.
Sanofi said it expects to reapply for approval in the first half of 2008, with the results of an ongoing trial on the drug.
Non-approvable letters are issued to a drug's sponsor when the agency does not find adequate data in a company's marketing application to warrant approval.
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