VONVENDI

STN: 125577
Proper Name: von Willebrand Factor (recombinant)
Tradename: VONVENDI
Manufacturer: Takeda Pharmaceuticals USA, Inc.
Indication:
VONVENDI [von Willebrand factor (recombinant)] is a recombinant von Willebrand factor (rVWF) indicated in adult and pediatric patients with von Willebrand disease (VWD) for:

• On-demand treatment and control of bleeding episodes.
• Perioperative management of bleeding.

For adult patients only:

• Routine prophylaxis to reduce the frequency of bleeding episodes. The documents identified as “Post to Web” in our CBER regulatory systems comprise the documents for posting this supplement approval.

Product Information

• Package Insert - VONVENDI

Supporting Documents

• September 5, 2025 Approval Letter - VONVENDI
• September 5, 2025 Clinical Review Memo - VONVENDI
• September 5, 2025 Statistical Review - VONVENDI
• 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