AstraZeneca ordered back into the penalty box on ZS-9 after another rejection on manufacturing malfunction
This one will really hurt at AstraZeneca.
Ten months after the pharma giant was sidelined on ZS-9 by manufacturing issues, the team at AstraZeneca is once again being put in the penalty box. The FDA has rejected the hyperkalemia drug — just as it did last May — following an inspection of the manufacturing center.
The agency isn’t looking for any new trials, but AstraZeneca will need to go back to the drawing board to figure out what’s wrong at its manufacturing facility. And that could take until early 2018.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.