Issued to Unicycive Therapeutics Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 29, 2026Application
NDA 505b1 • 218607
Product
NDA 218607
Company
Unicycive Therapeutics Inc.
Stage
Final Decision
Assyro regulatory brief
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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.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Unicycive Therapeutics Inc. on June 29, 2026.
NDA 218607 is the application under which FDA issued this complete response letter to Unicycive Therapeutics Inc.. The letter is dated June 29, 2026.
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.