Pfizer announced that the FDA has approved a prefilled dual-chamber syringe for administration of Xyntha (antihemophilic factor [recombinant]). The device will be used to deliver Xyntha by intravenous infusion after reconstitution of a freeze-dried powder with the diluent (0.9% sodium chloride), which are both supplied within the prefilled dual-chamber syringe.
The first prefilled dual-chamber syringe to be available will provide 3000 IU of Xyntha in 4mL. Other dosages of Xyntha will be available in the prefilled dual-chamber syringes in 2011.
Xyntha is a recombinant factor VIII product indicated for both the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A.
For more information call (800) 438-1985 or visit www.xyntha.com.