www.fdanews.com/articles/176911-fda-frowns-on-zs-pharmas-anda-for-hyperkalemia-candidate
FDA Frowns on ZS Pharma’s ANDA for Hyperkalemia Candidate
June 3, 2016
The FDA has rejected an ANDA submission from AstraZeneca subsidiary ZS Pharma for sodium zirconium cyclosilicate. In a complete response letter, the agency cited observations from a manufacturing inspection as the reason for its rejection, according to AstraZeneca.
AstraZeneca said the agency is not requesting additional clinical data.
The company is still in the process of evaluating the CRL and will work with the agency to determine its next moves.