Source facts
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. 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
ELFABRIO — FDA Complete Response Letter (BLA 761161)
Issued to Chiesi USA. Application reviewed but not approved; deficiencies must be corrected.
Issued
April 27, 2021Application
BLA • 761161
Product
ELFABRIO
Company
Chiesi USA
Review center
Other
Stage
Final Decision
Response due
January 1, 2024
Assyro regulatory brief
FreeWhat did FDA decide for ELFABRIO?
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
- 1Labeling, packaging, and proprietary name: 18 source-text matches.
Labeling, packaging, and proprietary name
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
Open the document workspaceFDA source document
Read the full FDA complete response letter (PDF)
Loading document viewer…
Common questions about the ELFABRIO complete response letter
What does this complete response letter mean for ELFABRIO?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Chiesi USA on April 27, 2021.
What is BLA 761161?
BLA 761161 is the application under which FDA issued this complete response letter for ELFABRIO to Chiesi USA. It was reviewed by FDA Other. The letter is dated April 27, 2021.
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.