Baxter announced that the FDA has approved BAXJECT III, a new reconstitution system for Advate (Antihemophilic Factor VIII [recombinant]).

The new reconstitution system was developed to reduce the number of steps in the reconstitution process for hemophilia A patients and caregivers, compared to the previous process with the BAXJECT II needle-less transfer device. A human factors study was performed with 44 participants to evaluate the safety and efficacy of using Advate with BAXJECT III reconstitution system. The BAXJECT III reconstitution system successfully met its performance goals in the study.

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Advate (Antihemophilic Factor [Recombinant]) is already approved for patients with hemophilia A to control and prevent hemorrhagic episodes, for perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Advate and the diluent will be available pre-packaged in the new BAXJECT III reconstitution system.

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