XYNTHA
STN: BL 125264
Proper Name: Antihemophilic Factor (Recombinant), Plasma/Albumin Free
Tradename: XYNTHA
Manufacturer: Wyeth Pahrmaceuticals, LLC
Indication:
- XYNTHA is a recombinant antihemophilic factor indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes.
- XYNTHA is not indicated in patients with von Willebrand’s disease.
Product Information
Supporting Documents
- August 13, 2020 Approval Letter - XYNTHA
- Clinical Review - XYNTHA
- Statistical Review - XYNTHA
- Supporting Documents older than three years - XYNTHA
- Approval History, Letters, Reviews, and Related Documents- XYNTHA