An FDA re-analysis of the ROCKET-AF trial of Janssen Pharmaceutical Cos.’s Xarelto (rivaroxaban) appears to close the books on the troubled, Robert Califf-led study by recommending against any labeling changes for the anticoagulant.
FDA Lifts Cloud Over J&J’s Xarelto With ROCKET-AF Re-Analysis
Agency reaffirms safety and efficacy in atrial fibrillation patients despite use of faulty coagulation monitoring device in pivotal trial led by current FDA Commissioner Robert Califf when he was at Duke University.
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