Issued to Unicycive Therapeutics Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 27, 2025Application
NDA 505b1 • 218607
Product
Unknown
Company
Unicycive Therapeutics Inc.
Review center
CDERStage
Final Decision
Response due
June 27, 2026
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 Unicycive Therapeutics Inc. on June 27, 2025.
NDA 218607 is the application under which FDA issued this complete response letter for Unknown to Unicycive Therapeutics Inc.. It was reviewed by FDA CDER. The letter is dated June 27, 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.