FDA Panel Won't Back J&J's Xarelto For ACS Patients

Law360, New York (May 23, 2012, 8:01 PM EDT) -- In a 6-4 decision, a U.S. Food and Drug Administration advisory committee on Wednesday recommended against approving Johnson & Johnson and Bayer AG blood thinner Xarelto for patients with acute coronary syndrome.

The members of the FDA Cardiovascular and Renal Drugs Advisory Committee expressed concerns that too many participants had dropped out of studies of the oral anti-coagulant and said they wondered what the analysis would have looked like if the dropout rate had been lower, according to representatives for Johnson & Johnson subsidiary Janssen Research...
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