Issued to AstraZeneca Pharmaceuticals LP. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 10, 2025Application
BLA • 761451
Product
SAPHNELO
Company
AstraZeneca Pharmaceuticals LP
Stage
Final Decision
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FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Statistical analysis. 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 Pharmaceuticals LP on October 10, 2025.
BLA 761451 is the application under which FDA issued this complete response letter for SAPHNELO to AstraZeneca Pharmaceuticals LP. The letter is dated October 10, 2025.
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.