(Reuters) - The U.S. Food and Drug Administration denied an approval to a wider use of Johnson & Johnson’s heart drug Xarelto.
The blood-clot preventing drug is already approved for use in multiple indications.
J&J’s unit Janssen Research & Development was seeking approval for using the drug to reduce the risk of heart problems, such as heart attack, stroke or death, in patients with acute coronary syndrome and to reduce the risk of stent thrombosis - a blood clot at the site of the stent.
J&J said it was evaluating the contents of the letters and would determine the appropriate next steps.
Reporting by Esha Dey in Bangalore; Editing by Kirti Pandey