AstraZeneca slapped with second Complete Response Letter
Having a potential blockbuster sidelined because of manufacturing issues is bad enough, but AstraZeneca has now had that experience twice—both times receiving a complete response letter from the FDA. For a second time, AstraZeneca has received a complete response letter tied to the manufacturing of the hyperkalemia treatment, a potential blockbuster treatment that was the target of AstraZeneca’s $2.7 billion buyout of ZS Pharma in 2015. Since getting its first CRL for the drug in May 2016, AstraZeneca has been joined by a number of other drug makers that have had drug launches sidelined by manufacturing problems....
