Issued to AstraZeneca AB. Application reviewed but not approved; deficiencies must be corrected.
Issued
September 30, 2019Application
NDA 505b1 • 212122
Product
BREZTRI AEROSPHERE
Company
AstraZeneca AB
Review center
Other
Stage
Final Decision
Response due
January 1, 2022
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Device constituent and human factors, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to AstraZeneca AB on September 30, 2019.
NDA 212122 is the application under which FDA issued this complete response letter for BREZTRI AEROSPHERE to AstraZeneca AB. It was reviewed by FDA Other. The letter is dated September 30, 2019.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.