Proper Name: von Willebrand factor (Recombinant)
Manufacturer: Baxalta US Inc.
- Indicated for on-demand treatment, control of bleeding episodes and perioperative management of bleeding in adults diagnosed with von Willebrand disease.
- 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.
- December 8, 2015 Approval Letter - VONVENDI
- December 8, 2015 Summary Basis for Regulatory Action - VONVENDI
- Approval History, Letters, Reviews, and Related Documents - VONVENDI