STN: BL 125566
Proper Name: Antihemophilic Factor (Recombinant), PEGylated
Tradename: ADYNOVATE
Manufacturer: Baxalta US Inc.
Indication: 

• Indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes;  (2) Perioperative management; (3) Routine prophylaxis to reduce the frequency of bleeding episodes.

Product Information

• Package Insert - ADYNOVATE
• Package Insert - ADYNOVATE (with external housing)

Supporting Documents

• 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