FDA Denies Expanded Approval of J&J Blood Thinner
Federal regulators have denied Johnson & Johnson’s request to expand approval of its blood thinner Xarelto for a new use to prevent life-threatening blood clots in high-risk patients.
J&J said Thursday the Food and Drug Administration responded to the company’s request with additional questions about the proposed new use of the drug.
The company already markets Xarelto for two patient groups: those with irregular heartbeat and those undergoing hip- or knee-replacement surgery.
New Brunswick, N.J.-based J&J asked the FDA to approve Xarelto as a means to prevent blood clots in patients with acute coronary artery disease.
Last month an FDA panel of experts voted 6-4 against expanding use of the pill, saying too much information was missing from company studies to accurately gauge the drug’s benefit.
(Copyright 2012 by The Associated Press. All Rights Reserved.)