The Food and Drug Administration has granted 510(k) clearance to myPKFiT for ADVATE (Antihemophilic Factor, Recombinant), pharmokinetic dosing software used for tailoring prophylaxis regimens for hemophilia A patients.
The software can be used for hemophilia A patients aged 16 years or older who weigh at least 45 kilograms (about 99 pounds) and are treated with ADVATE.
The software is expected to be available in the United States by the end of the first quarter of 2018. A version of the software is already marketed in Europe.