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Andexxa FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved May 3, 2018)
Brand name: Andexxa
Generic name: coagulation factor Xa (recombinant), inactivated-zhzo
Company: Portola Pharmaceuticals, Inc.
Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors

Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human Factor Xa (FXa) protein indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Development timeline for Andexxa

May  3, 2018Approval FDA Approves Portola Pharmaceuticals’ Andexxa, First and Only Antidote for the Reversal of Factor Xa Inhibitors
Aug 18, 2016Portola Pharmaceuticals Receives Complete Response Letter from FDA for Biologics License Application for AndexXa (andexanet alfa)
Feb 17, 2016Portola Pharmaceuticals Announces BLA for Andexanet Alfa Accepted for Review by FDA
Dec 18, 2015Portola Pharmaceuticals Completes BLA Submission to U.S. Food and Drug Administration for Andexanet Alfa

Further information

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