Issued to Fresenius Kabi USA, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 27, 2026Application
NDA 505b1 • 215818
Product
NDA 215818
Company
Fresenius Kabi USA, LLC
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, Nonclinical evidence. 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 Fresenius Kabi USA, LLC on February 27, 2026.
NDA 215818 is the application under which FDA issued this complete response letter to Fresenius Kabi USA, LLC. The letter is dated February 27, 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.