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FDA to review new NDA for AstraZeneca’s hyperkalemia drug

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The U.S. Food and Drug Administration has accepted for review AstraZeneca’s re-submission of a new drug application for the hyperkalemia drug sodium zirconium cyclosilicate (ZS-9). The FDA has indicated that this is a complete class 2 response.

AstraZeneca announced in May that the FDA had rejected the new drug application for ZS-9 due to observations arising from a pre-approval manufacturing inspection.

Interactions with other health authorities in the European Union and Australia are ongoing with decisions expected in the first half of 2017, the company said.