Proper Name: von Willebrand factor (Recombinant)
Manufacturer: Baxalta US Inc.
- Indicated for on-demand treatment, control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease receiving on-demand therapy.
- January 28, 2022 Approval Letter - VONVENDI
- April 13, 2018 Summary Basis for Regulatory Action - VONVENDI
- April 13, 2018 Approval Letter - Vonvendi
To include a new indication and usuage for the perioperative management of bleeding, based on data from a Phase 3 Study.
- Approval History, Letters, Reviews, and Related Documents - VONVENDI
- Supporting Documents older than three years - VONVENDI