PARIS, March 8 The U.S. Department of Justice
(DoJ) is investigating disclosures to the Food & Drug
Administration (FDA) about the variable response that certain
patients may have to blood-thinner Plavix, Sanofi said
in its annual report.
The French drugmaker said it had became aware of the probe
in June 2012 and was cooperating with the DoJ.
Plavix, once the world's second-best selling drug, was
co-marketed by Sanofi and U.S. drugmaker Bristol-Myers Squibb
before it lost patent protection in May 2012.
The U.S. FDA added a so-called boxed warning to Plavix in
2010 to highlight that the drug could be less effective in
certain patients who could not metabolize it properly.
A Sanofi spokeswoman declined to elaborate on the statement
in the annual report.
The DoJ and Bristol Myers Squibb were not immediately
available for comment.