Issued to Novo Nordisk Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 10, 2024Application
BLA • 761326
Product
AWIQLI FLEXTOUCH
Company
Novo Nordisk Inc.
Review center
CBERStage
Final Decision
Response due
July 10, 2025
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Clinical efficacy and substantial evidence, Chemistry, manufacturing, and controls. 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 Novo Nordisk Inc. on July 10, 2024.
BLA 761326 is the application under which FDA issued this complete response letter for AWIQLI FLEXTOUCH to Novo Nordisk Inc.. It was reviewed by FDA CBER. The letter is dated July 10, 2024.
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.