NEW BRUNSWICK, N.J. (AP) - Johnson & Johnson has given the Food and Drug Administration additional data to on its new anticlotting drug, in a second attempt to get approval for more uses.
Xarelto is approved for reducing risk of blood clots in people who've had knee or hip replacement surgery and reducing stroke risk in people with an irregular heartbeat.
J&J sought approval to market Xarelto for preventing a second heart attack or stroke in patients at high risk because of a narrowed heart artery, and for preventing blood clots from forming around stents, tiny metal-mesh scaffolds that prop open heart arteries.
The FDA turned down one application in June. J&J then withdrew the second. Now it's sent the FDA data from a huge study showing Xarelto prevented strokes, heart attacks and deaths.
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