The FDA has issued a Complete Response Letter (CRL) to the Biologics License Application (BLA) of AndexXa (andexanet alfa; Portola) as a reversal agent for life-threatening or uncontrolled bleeding due to Factor Xa inhibitors.
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Portola Pharmaceuticals announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for its investigational agent andexanet alfa, as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled bleeding event or who require urgent or emergency surgery. There is currently no…
Accu-Break Pharmaceuticals (ABP) announced that the Food & Drug Administration (FDA) has accepted for filling the New Drug Application (NDA) for Warfarin Potassium.