AstraZeneca (AZN.L) announced the US FDA has issued a Complete Response Letter regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate). The CRL followed an inspection by the FDA of the ZS-9 manufacturing facility. The CRL does not require the generation of any new clinical data.
Sodium zirconium cyclosilicate is being developed for the treatment of hyperkalaemia by ZS Pharma, a subsidiary of AstraZeneca.
by RTT Staff Writer
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