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
REZVOGLAR — FDA Complete Response Letter (BLA 761215)
Issued to Eli Lilly and Company. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 17, 2021Application
BLA • 761215
Product
REZVOGLAR
Company
Eli Lilly and Company
Review center
Other
Stage
Final Decision
Response due
November 13, 2026
Assyro regulatory brief
FreeWhat did FDA decide for REZVOGLAR?
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Key details in this letter
- 1Labeling, packaging, and proprietary name: 14 source-text matches.
Labeling, packaging, and proprietary name
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the REZVOGLAR complete response letter
What does this complete response letter mean for REZVOGLAR?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Eli Lilly and Company on December 17, 2021.
What is BLA 761215?
BLA 761215 is the application under which FDA issued this complete response letter for REZVOGLAR to Eli Lilly and Company. It was reviewed by FDA Other. The letter is dated December 17, 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.