FDA again reviewing AZ's hyperkalemia candidate

AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA accepted a resubmitted NDA for ZS-9 to treat hyperkalemia. In May, AZ received a complete response letter in which FDA cited "observations arising from a pre-approval manufacturing inspection" (see BioCentury Extra, May 27).

ZS-9 is an inorganic crystal form of zirconium silicate designed to trap potassium ions over other ions throughout the GI tract. The pharma did not respond to an inquiry about the candidate's new PDUFA date or manufacturing changes. ...