FDA nod for Flexbumin production at new plasma facility in Georgia

The US Food and Drug Administration has approved Japanese drug major Takeda Pharmaceutical’s (TYO: 4502) second submission for its new plasma manufacturing facility near Covington, Georgia for the production of Flexbumin L25% [albumin (human)], USP, 25% Solution, indicated for hypovolemia, hypoalbuminemia, (burns, adult respiratory distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN).

The Georgia facility received its first FDA approval, to manufacture GammaGard Liquid [immune globulin infusion (human)] 10% Solution, in June 2018.