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 Package Insert - ADYNOVATE 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