ADYNOVATE
STN: BL 125566
Proper Name: Antihemophilic Factor (Recombinant) PEGylated
Tradename: ADYNOVATE
Manufacturer: Takeda Pharmaceuticals U.S.A., Inc.
Indication:
TADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for:
- On-demand treatment and control of bleeding episodes
- Perioperative management
- Routine prophylaxis to reduce the frequency of bleeding episodes.
Product Information
Supporting Documents
- October 10, 2025 Approval Letter - ADYNOVATE
- August 9, 2023 Approval Letter - ADYNOVATE
- Statistical Review - ADYNOVATE
- Clinical Review Memo - ADYNOVATE
- June 14, 2021 Approval Letter - ADYNOVATE
- December 19, 2016 Clinical Review - ADYNOVATE
- October 28, 2016 Statistical Review - ADYNOVATE
- November 9, 2015 Clinical Review - ADYNOVATE
- October 1, 2015 Statistical Review - ADYNOVATE
- Supporting Documents older than three years - ADYNOVATE
- Approval History, Letters, Reviews, and Related Documents - ADYNOVATE