STN: 125771
Proper Name: antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
Tradename: ALTUVIIIO
Manufacturer: Bioverativ Therapeutics Inc., a Sanofi Company
Indication:

• For adults and children with Hemophilia A (congenital Factor VIII deficiency) for: (1) Routine prophylaxis to reduce the frequency of bleeding episodes; (2) On-demand treatment and control of bleeding episodes; and (3) Perioperative management of bleeding.

Product Information

• Package Insert - ALTUVIIIO

Supporting Documents

• February 22, 2023 Approval Letter - ALTUVIIIO
• February 22, 2023 Approval Replacement Letter - ALTUVIIIO
• February 21, 2023 Summary Basis for Regulatory Action - ALTUVIIIO
• Approval History, Letters, Reviews, and Related Documents - ALTUVIIIO