Issued to LIB Therapeutics, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 12, 2025Application
BLA • 761427
Product
LEROCHOL
Company
LIB Therapeutics, Inc.
Stage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. 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.
Open the document workspaceFDA source document
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to LIB Therapeutics, Inc. on December 12, 2025.
BLA 761427 is the application under which FDA issued this complete response letter for LEROCHOL to LIB Therapeutics, Inc.. The letter is dated December 12, 2025.
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.