Xarelto Label Expansion Plans Slowed By FDA “Complete Response” On ACS Claim
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The agency’s decision not to approve the Factor Xa inhibitor for treating acute coronary syndrome patients follows a negative recommendation by an FDA advisory committee, which was concerned about missing data in the pivotal ATLAS trial. FDA may be seeking more clarity on the issue of missing vital status follow-up for patients who withdrew consent in that study.
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