PARIS (AP) — Sanofi says the U.S. Justice Department is investigating the drugmaker’s disclosures to the Food and Drug Administration on its blockbuster blood thinner Plavix.
The French company said in a filing with the Securities and Exchange Commission last week that it learned in June about the investigation, which centers on differing responses to the drug.
It did not elaborate, but in 2010, the FDA warned that certain patients with a genetic variation cannot metabolize Plavix, increasing their risk for heart attack and stroke. The drug is jointly marketed with Bristol-Myers Squibb.
Sanofi says it is cooperating with the investigation.
Before it got U.S. generic competition last May, Plavix was the No. 2 drug in the world by revenue, with annual sales of around $9 billion in 2011.