Wyeth Pharmaceuticals has announced the FDA approval of BeneFIX R2 Kit
Wyeth Pharmaceuticals has announced the FDA approval of BeneFIX R2 Kit, an updated version of the currently available product BeneFIX Coagulation Factor IX (recombinant). Four enhancements have been made, including a 2,000 IU dosage vial, a needleless reconstitution device, a prefilled diluent syringe, and a reduced diluent volume. According the manufacturer, the lower diluent volume and the prefilled syringe will allow for easier product preparation. The BeneFIX R2 Kit is indicated for the control and prevention of hemorrhagic episodes including control and prevention in surgical settings in patients with hemophilia B, also known as congenital factor IX deficiency or Christmas disease. Wyeth expects the new product to be available in mid-2007.