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US FDA snubs Janssen's Xarelto for acute coronary syndrome

This article was originally published in Scrip

Executive Summary

Janssen Research & Development's (sNDA), a subsidiary of Johnson & Johnson, failed in its attempt to have the labelling expanded for its anticoagulant Xarelto (rivaroxaban) as a therapy to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS), with the US FDA taking its outside experts' advice to reject that indication.



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