Federal Register Notice: FDA has determined that the regulatory review period for Baxter International, Inc.’s Extranael (icodextrin) is 2,207 days for the extension of a patent that claims that human drug product. Extranael is indicated for a single daily exchange for the long (eight-to 16-hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of chronic renal failure. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce. To view this notice, click here.
