Posts Tagged ‘NDA’

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December 29th, 2011

J&J Applies for ACS Indication for Rivaroxaban (Xarelto)

Based on the promising results of the recently published ATLAS ACS 2 TIMI 51 trial, Johnson & Johnson has submitted a supplemental new drug application to the FDA for the approval of rivaroxaban (Xarelto) to reduce the risk of thrombotic cardiovascular events in ACS patients. Following a succession of failed trials, ATLAS was the first trial to […]