FDA panel declines to recommend new approval for J&J anticlotting drug

Drug maker seeks approval for new use of Xarelto

RARITAN, N.J. — A Food and Drug Administration expert panel has recommended against expanding the approval of a Johnson & Johnson drug, the company said.

J&J subsidiary Janssen Research & Development said the FDA's Cardiovascular and Renal Drugs Advisory Committee voted against recommending approval of Xarelto (rivaroxaban) combined with antiplatelet drugs to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome.

The FDA is not required to follow the recommendations of advisory committees, but usually does. Xarelto already is approved for reducing the risk of blood clots in patients who have had knee or hip replacement surgery and for reducing the risk of strokes and other blood clots in certain people with atrial fibrillation.

 


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