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AstraZeneca's ZS-9 Timeline Hit By FDA Complete Response Letter

This article was originally published in The Pink Sheet Daily

Executive Summary

A manufacturing issue at a plant in Texas has resulted in a complete response letter from the FDA, dashing AstraZeneca's hopes that its potential best-in-class treatment for hyperkalemia, ZS-9, would be approved in this year's first half – but the good news is that no new clinical data is required on the drug.

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