Issued to Fresenius Kabi USA, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
April 25, 2025Application
NDA 505b1 • 215818
Product
Unknown
Company
Fresenius Kabi USA, LLC
Review center
CDERStage
Final Decision
Response due
April 25, 2026
Assyro regulatory brief
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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 April 25, 2025.
NDA 215818 is the application under which FDA issued this complete response letter for Unknown to Fresenius Kabi USA, LLC. 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.