Xarelto Approval For Stroke Prevention Sets Up Marketing Battle With Pradaxa
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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.
Eliquis Superiority Claim May Be At Stake In “Complete Response” Letter
FDA could have concerns about the reported data from the ARISTOTLE trial, either from the bleeding comparisons or the dosing in the warfarin control arm. Missing data is another possible issue, as in the recent “complete response” letter for J&J/Bayer’s Xarelto.
Eliquis Superiority Claim May Be At Stake In “Complete Response” Letter
FDA could have concerns about the reported data from the ARISTOTLE trial, either from the bleeding comparisons or the dosing in the warfarin control arm. Missing data is another possible issue, as in the recent “complete response” letter for J&J/Bayer’s Xarelto.