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

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.