Issued to University of California San Francisco. Application reviewed but not approved; deficiencies must be corrected.
Issued
April 25, 2025Application
NDA 505b1 • 218353
Product
floretyrosine F 18
Company
University of California San Francisco
Review center
CDERStage
Final Decision
Response due
April 25, 2026
Assyro regulatory brief
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to University of California San Francisco on April 25, 2025.
NDA 218353 is the application under which FDA issued this complete response letter for floretyrosine F 18 to University of California San Francisco. It was reviewed by FDA CDER. The letter is dated April 25, 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.