Source facts
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
US FDA source recordCRL · Complete Response Letter
rebisufligene etisparvovec — FDA Complete Response Letter (125845)
Issued to Ultragenyx Pharmaceutical Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 7, 2025Application
Other • 125845
Product
rebisufligene etisparvovec
Company
Ultragenyx Pharmaceutical Inc.
Review center
CBERStage
Final Decision
Response due
July 7, 2026
Assyro regulatory brief
FreeWhat did FDA decide for rebisufligene etisparvovec?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1Chemistry, manufacturing, and controls: 1 source-text match.
Chemistry, manufacturing, and controls
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the rebisufligene etisparvovec complete response letter
What does this complete response letter mean for rebisufligene etisparvovec?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Ultragenyx Pharmaceutical Inc. on July 7, 2025.
What is 125845?
125845 is the application under which FDA issued this complete response letter for rebisufligene etisparvovec to Ultragenyx Pharmaceutical Inc.. It was reviewed by FDA CBER. The letter is dated July 7, 2025.
What happens after an FDA complete response letter?
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.