The Food and Drug Administration (FDA) has sent AstraZeneca a complete response letter (CRL) from the regulatory board in response to the development of sodium zirconium cyclosilicate, a drug designed to treat hyperkalaemia.
The letter does not ask for any new clinical data, according to a press release.
The letter followed an FDA inspection of the manufacturing facility for sodium zirconium cyclosilicate. AstraZeneca and its subsidiary ZS Pharma will work with the FDA to resolve any matters that are under review, according to the release.
Sodium zirconium cyclosilicate recently received a positive opinion by the Committee for Medicinal Products for Human Use in the European Union.
AstraZeneca receives complete response letter from FDA
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