FDA denies approval to wider use of J&J's blood clot preventer
Feb 14 (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.
- Malaysia jet sent 'pings' after going missing, sources say |
- Russia holds war games near Ukraine; Merkel warns of catastrophe |
- New York City gas explosion subject of federal probe |
- White House tried to mediate dispute between Senate, CIA panel: source
- Missing jet may have strayed to west, Malaysia military says |