Issued to Eli Lilly and Company. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 18, 2023Application
BLA • 761248
Product
KISUNLA
Company
Eli Lilly and Company
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
Assyro regulatory brief
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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 January 18, 2023.
BLA 761248 is the application under which FDA issued this complete response letter for KISUNLA to Eli Lilly and Company. It was reviewed by FDA Other. The letter is dated January 18, 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.