Additional Relevant Details FDA) has approved the BAXJECT III reconstitution system for ADYNOVATE [Antihemophilic Factor, (Recombinant), PEGylated]. The new system reduces the number of steps in the reconstitution process for hemophilia A patients and caregivers. ADYNOVATE and the diluent will be pre-packaged in the BAXJECT III reconstitution system.

The BAXJECT III reconstitution system reduces the number of steps in the treatment process by two, compared to the previous process with the BAXJECT II Hi Flow Needleless transfer device. The BAXJECT III system with ADYNOVATE will be available to most customers in the fourth quarter of 2016, with a 2 mL diluent for the 250, 500, and 1000 IU potencies; and a 5 mL diluent for the 2000 IU potency.