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FDA document lays out issues undermining approval of AstraZeneca's ZS Pharma drug

Safi Bello

Fierce Pharma -------- The FDA has twice rejected AstraZeneca’s application for a new drug to treat hyperkalemia because of manufacturing concerns. The reasons why became clearer Wednesday when the agency posted a document outlining the issues that have regulators furrowing their brows. The highly redacted FDA Form 483 was issued (PDF) to AstraZeneca’s ZS Pharma unit following a January inspection of its plant in Coppell, Texas. That's where it is manufacturing ZS-9, a potential blockbuster treatment that was the target in AstraZeneca’s $2.7 billion buyout of ZS Pharma in 2015. To learn more click on the picture below to read the article.

FDA document lays out issues undermining approval of AstraZeneca's ZS Pharma drug - Read More from Fierce Pharma

 
 
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