Posted by Michael Wonder on 18 Oct 2016
FDA accepts for review new drug application for sodium zirconium cyclosilicate for the treatment of hyperkalaemia
18 October 2016 - AstraZeneca today announced that the US FDA has accepted a complete re-submission of a new drug application for sodium zirconium cyclosilicate (ZS-9), a potential new medicine for the treatment of hyperkalaemia by ZS Pharma, a wholly-owned subsidiary of AstraZeneca.
The FDA has indicated that this is a complete class 2 response.
Interactions with other health authorities in the European Union and Australia are ongoing with decisions expected in the first half of 2017.
