STN: BL 125566
Proper Name: Antihemophilic Factor (Recombinant), PEGylated
Manufacturer: Baxalta US Inc.
- 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.
- December 23, 2016 Summary Basis for Regulatory Action - ADYNOVATE
- December 22, 2016 Approval Letter - ADYNOVATE
To expand the clinical indication to include children (less than 12 years of age).
- December 19, 2016 Clinical Review - ADYNOVATE
- October 28, 2016 Statistical Review - ADYNOVATE
- November 13, 2015 Approval Letter - ADYNOVATE
- November 13, 2015 Summary Basis for Regulatory Action - ADYNOVATE
- November 9, 2015 Clinical Review - ADYNOVATE
- October 1, 2015 Statistical Review - ADYNOVATE
- Approval History, Letters, Reviews, and Related Documents - ADYNOVATE