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RARITAN, N.J. — The Food and Drug Administration has given priority review to a regulatory application from Johnson & Johnson for a drug designed to reduce the risk of complications from internal blood clots.
J&J's Janssen Research & Development division announced that the FDA had given the designation to Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of certain types of heart attacks in patients with acute coronary syndrome, which 1.2 million Americans are diagnosed with every year.
The agency gives priority review to medicines that represent advances in care or provide a treatment where no adequate therapy exists, J&J said. The designation allows the FDA to finish reviewing an application for a drug in six months rather than the usual 10.