Issued to Eli Lilly and Company. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 30, 2023Application
BLA • 761279
Product
OMVOH
Company
Eli Lilly and Company
Review center
Other
Stage
Final Decision
Response due
January 1, 2024
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. 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 Eli Lilly and Company on March 30, 2023.
BLA 761279 is the application under which FDA issued this complete response letter for OMVOH to Eli Lilly and Company. It was reviewed by FDA Other. The letter is dated March 30, 2023.
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.