AstraZeneca Receives Complete Response Letter for ManufacturingBy
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to AstraZeneca following an inspection by the FDA of the manufacturing facility for ZS-9 (sodium zirconium cyclosilicate), a drug candidate referenced in a new drug application that is being developed for treating hyperkalemia, or high potassium levels in the blood serum, by ZS Pharma, a wholly-owned subsidiary of AstraZeneca.
The CRL does not require the generation of any new clinical data, according to AstraZeneca. Sodium zirconium cyclosilicate received a positive opinion in the European Union in February 2017 by the Committee for Medicinal Products for Human Use of the European Medicines Agency. Any potential implications for ongoing regulatory submissions are being assessed by the company.