Content about Interventional cardiology

June 28, 2013

The Food and Drug Administration has declined to approve a drug made by Johnson & Johnson for patients who have received coronary stent implants.

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.