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FDA accepts NDA for ZS Pharma hyperkalemia candidate

July 30, 2015 1:08 AM UTC

ZS Pharma Inc. (NASDAQ:ZSPH) said FDA accepted for review an NDA for sodium zirconium cyclosilicate ( ZS-9) to treat hyperkalemia. The PDUFA date is May 26, 2016.

The inorganic crystal form of zirconium silicate designed to trap potassium ions over other ions throughout the GI tract met the primary endpoint of the Phase III HARMONIZE trial last year and the Phase III ZS-003 study in 2013 (see BioCentury Extra, Sept. 23, 2014). ...