Issued to SYDNEXIS Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 22, 2025Application
NDA 505b1 • 219694
Product
NDA 219694
Company
SYDNEXIS 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 Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Safety and adverse events, Statistical analysis. 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 SYDNEXIS Inc. on October 22, 2025.
NDA 219694 is the application under which FDA issued this complete response letter to SYDNEXIS Inc.. The letter is dated October 22, 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.