Issued to Novo Nordisk. Application reviewed but not approved; deficiencies must be corrected.
Issued
April 24, 2023Application
BLA • 761315
Product
ALHEMO
Company
Novo Nordisk
Review center
Other
Stage
Final Decision
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Safety and adverse events, Clinical efficacy and substantial evidence. 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 on April 24, 2023.
BLA 761315 is the application under which FDA issued this complete response letter for ALHEMO to Novo Nordisk. It was reviewed by FDA Other. The letter is dated April 24, 2023.
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.