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