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RARITAN, N.J. — The Food and Drug Administration has declined to approve a drug made by Johnson & Johnson for patients who have received coronary stent implants.
J&J subsidiary Janssen Research & Development said Friday that the FDA issued a complete response letter for Xarelto (rivaroxaban) to reduce the risk of stent thrombosis in patients with acute coronary syndrome. Stent thrombosis is when blood pools at the site of a stent in the patient's coronary artery and, while uncommon, is serious and can cause a heart attack and death.
The FDA issues a complete response letter when it has finished reviewing a drug application, but questions remain that preclude final approval, and Janssen said it would continue discussions with the FDA. Xarelto is already approved for treating certain blood clots.