FDA Once Again Rejects New Indication For Rivaroxaban Reply

The third time wasn’t the charm. The FDA today turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in the same population for the reduction of stent thrombosis.

Click here to read the full post on Forbes.

 

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