Baxter International has received approval from US Food and Drug Administration (FDA) for its Phoxillum Renal Replacement Solutions (BK4/2.5 and B22K4/0) to use as replacement solutions in continuous renal replacement therapy (CRRT).
The therapy aims to correct electrolyte and acid-base imbalances.
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In addition, Phoxillum can be used in case of drug poisoning when CRRT is used to remove dialysable substances.
Baxter vice-president and renal therapeutic area lead Bruce Culleto said: "The approval of Phoxillum allows us to offer healthcare providers additional options in managing critically ill acute kidney injury patients treated with CRRT.
"Introducing products like Phoxillum is part of Baxter’s commitment to offering healthcare providers a range of therapy options for patients."
Phoxillum was developed to treat hypophosphatemia in patients with CRRT, and is said to be the only FDA approved pre-mixed solution containing phosphate in a 5l bag.
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By GlobalDataAccording to Baxter, Phoxillum will facilitate electrolyte management during CRRT, by allowing use of a single type of solution across a wide clinical spectrum of acute kidney injury (AKI) patients.
Developed for paediatric and adult patients, the approval comprises Phoxillum formulations containing different bicarbonate concentrations.
The company plans to start marketing of Phoxillum phosphate-containing solutions in the second quarter of 2015, in the US. Phoxillum also received orphan drug designation from FDA for use in CRRT.
Image: Baxter building in Vienna. Photo: courtesy of Gerd Fahrenhorst.
