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Anticoagulant Therapy

Rivaroxaban for ACS Denied

The FDA advisory committee yesterday, January 16, 2013, unanimously withheld clearance for rivaroxaban’s acute coronary syndrome indication. Details appear in today’sMedscape Oncology Heartwire headline. This is the third time that Janssen’s application has been denied for this indication. Rivaroxaban is cleared for stroke  prevention in atrial fibrillation, thrombosis prevention following total hip or knee replacement […]
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Rivaroxaban for ACS?

Announcement provided by Ali Sadeghi-Khomami, PhD; Research and Development Manager, Precision BioLogic Inc: In documents released ahead of an FDA advisory panel meeting on January 16, agency staff on Tuesday expressed skepticism that the data submitted by Johnson & Johnson demonstrate that Xarelto (rivaroxaban) is effective for treating acute coronary syndrome (ACS) in patients with a previous history […]
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