Issued to Astellas Pharma US, Inc. Application reviewed but not approved; deficiencies must be corrected.
Issued
November 15, 2024Application
NDA 505b1 • 217225
Product
IZERVAY
Company
Astellas Pharma US, Inc
Review center
Other
Stage
Final Decision
Response due
November 13, 2026
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Statistical analysis. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Astellas Pharma US, Inc on November 15, 2024.
NDA 217225 is the application under which FDA issued this complete response letter for IZERVAY to Astellas Pharma US, Inc. It was reviewed by FDA Other. The letter is dated November 15, 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.