Issued to Sentynl Therapeutics, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
September 30, 2025Application
NDA 505b1 • 211241
Product
ZYCUBO
Company
Sentynl 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, 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.
Open the document workspaceFDA source document
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Sentynl Therapeutics, Inc. on September 30, 2025.
NDA 211241 is the application under which FDA issued this complete response letter for ZYCUBO to Sentynl Therapeutics, Inc.. The letter is dated September 30, 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.