Issued to Amneal EU, Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
April 2, 2025Application
NDA 505b1 • 218345
Product
Unknown
Company
Amneal EU, Limited
Review center
CDERStage
Final Decision
Response due
April 2, 2026
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 Amneal EU, Limited on April 2, 2025.
NDA 218345 is the application under which FDA issued this complete response letter for Unknown to Amneal EU, Limited. It was reviewed by FDA CDER. The letter is dated April 2, 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.