STN: BLA 125586
Proper Name: coagulation factor Xa (recombinant), inactivated-zhzo
Trade Name: ANDEXXA
Manufacturer: Portola Pharmaceuticals, Inc.
Indication:

• For patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Product Information

• 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.

Supporting Documents

• 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