This article was originally published in Pharmaceutical Approvals Monthly
Bayer's peritoneal dialysis (PD) solution Extraneal is approved Dec. 20. Extraneal contains a novel osmotic agent (a polymer of glucose) that the firm says offers the potential for increased removal of fluid from the blood stream over currently available 1.5% and 2.5% dextrose solutions. In clinical trials, Extraneal showed higher net ultrafiltration than both dextrose solutions, as well as higher creatinine and urea nitrogen clearances than 2.5% dextrose. Extraneal is indicated for a single daily exchange for the long dwell (8- to 16-hours) during continuous ambulatory PD or automated PD for the management of chronic renal failure. Bayer is working on educational programs regarding potential effects on glucose tests as a postmarketing commitmen
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