In a harsh warning letter, the FDA has reprimanded Sanofi-Aventis for failing to meet regulatory deadlines for reporting serious side effects with many of its drugs, including the Lovenox blood thinner, the Multaq heart drug and the Allegra D allergy pill, and also did not report post-marketing studies or completed, unpublished clinical trials in NDA annual reports.
Read article at pharmalot.com
Friday, February 25, 2011
Sanofi Failed To Report Side Effects
Posted by Willow at 11:36 am
Labels: adverse side-effects, Allegra D, drug side-effects, FDA, Lovenox, Multaq, Sanofi-Aventis
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