Source facts
FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance. 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
EYDENZELT — FDA Complete Response Letter (BLA 761377)
Issued to CELLTRION, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 27, 2024Application
BLA • 761377
Product
EYDENZELT
Company
CELLTRION, Inc.
Review center
CBERStage
Final Decision
Response due
June 27, 2025
Assyro regulatory brief
FreeWhat did FDA decide for EYDENZELT?
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
- 1Facility inspection and CGMP compliance: 11 source-text matches.
Facility inspection and CGMP compliance
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the EYDENZELT complete response letter
What does this complete response letter mean for EYDENZELT?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to CELLTRION, Inc. on June 27, 2024.
What is BLA 761377?
BLA 761377 is the application under which FDA issued this complete response letter for EYDENZELT to CELLTRION, Inc.. It was reviewed by FDA CBER. The letter is dated June 27, 2024.
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.