AstraZeneca receives complete response letter from FDA
The letter does not ask for any new clinical data, according to a press release.
The letter followed an FDA inspection of the manufacturing facility for sodium zirconium cyclosilicate. AstraZeneca and its subsidiary ZS Pharma will work with the FDA to resolve any matters that are under review, according to the release.
Sodium zirconium cyclosilicate recently received a positive opinion by the Committee for Medicinal Products for Human Use in the European Union.
Organizations in this story
AstraZeneca Pharmaceuticals LP 1800 Concord Pike Wilmington, DE 19803
U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903