Issued to Fresenius Kabi USA, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 11, 2024Application
NDA 505b1 • 214610
Product
Unknown
Company
Fresenius Kabi USA, LLC
Review center
CDERStage
Final Decision
Response due
December 11, 2025
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 December 11, 2024.
NDA 214610 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 December 11, 2024.
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.