ANDEXXA
STN: BLA 125586
Proper Name: coagulation factor Xa (recombinant), inactivated-zhzo
Trade Name: ANDEXXA
Manufacturer: AstraZeneca AB
Indication:
- Indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
- Package Insert - ANDEXXA
- Demographic Subgroup Information - coagulation factor Xa (recombinant), inactivated-zhzo [ANDEXXA]
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- Update on the Safety of Andexxa
December 18, 2025
- March 28, 2024 Approval Letter - ANDEXXA
- May 20, 2022 Approval Letter - ANDEXXA
- December 31, 2018 Approval Letter - ANDEXXA
- May 3, 2018 Approval Letter - ANDEXXA
- May 3, 2018 Summary Basis for Regulatory Action - ANDEXXA
- Office Director's Memo, May 2, 2018 - ANDEXXA
- Approval History, Letters, Reviews, and Related Documents 1 - ANDEXXA
- Approval History, Letters, Reviews, and Related Documents 2 - ANDEXXA
- Approval History, Letters, Reviews, and Related Documents 3 - ANDEXXA
- Approval History, Letters, Reviews, and Related Documents 4 - ANDEXXA
- Approval History, Letters, Reviews, and Related Documents 5 - ANDEXXA