ML Labs gets US backing for dialysis solution

ML Laboratories' peritoneal dialysis solution Extraneal (icodextrin) hasbeen recommended for approval by the US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee. If the agency concurs with this verdict and approves the drug, Extraneal would be the first solution with a new osmotic agent introduced for peritoneal dialysis patients in the USA since 1978, according to ML.

ML licenses rights to Extraneal to Baxter Healthcare Corp, which currently has approval to market the product in 31 countries. It is used by approximately 30% of all peritoneal dialysis patients in Europe, and is expected to reach the US market in 2002.

Meanwhile, ML notes that the FDA has also completed an inspection of its manufacturing facility for icodextrin, which is based in Liverpool, UK, and given it the all-clear.