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FDA Delays AndexXa Antidote for Xarelto Bleeding

As part of a continued review process, the AndexXa antidote developed to cease potentially-fatal Xarelto bleeding side effects remains unapproved. The Food and Drug Administration (FDA) has initiated a 90-day extension until May 2018, citing the need for more data.

For tens of thousands of patients who have required hospitalization due to Xarelto bleeding, an antidote is greatly needed. But that does not mean the FDA should rush the process.

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