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FDA Rejects Wider Use of J&J's Xarelto for 3rd Time

By Associated Press - Feb 14, 2014 at 1:17PM

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The federal advisors said too much information was missing from company studies to accurately gauge Xarelto's benefit.

WASHINGTON (AP) -- Johnson & Johnson said Friday that the Food and Drug Administration has rejected -- for a third time -- its application to expand use of the blood thinner Xarelto to reduce dangerous blood clots and related problems in patients with coronary artery disease.

The condition occurs when narrowed blood vessels restrict blood flow to the heart, increasing the risk of heart attack and other potentially deadly problems

The FDA's rejection letter, announced by J&J, was expected after an FDA panel of experts unanimously voted against the broader use of the pill last month. The federal advisors said too much information was missing from company studies to accurately gauge Xarelto's benefit.

The FDA also rejected a second indication to reduce blood clots in patients who have received a stent, a mesh-metal tube used to open arteries that have been cleared of fatty plaque.

J&J said it a statement: "We are evaluating the contents of the letters and will determine the appropriate next steps."

The New Brunswick, N.J.-based company already markets the pill for three patient groups: Those with irregular heartbeats, those undergoing hip or knee replacement surgery, and those at risk of blood clots in the legs.

J&J reported Xarelto sales of $246 million in its last fiscal quarter.


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