Issued to Aldeyra Therapeutics, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 16, 2026Application
NDA 505b1 • 216442
Product
NDA 216442
Company
Aldeyra Therapeutics, Inc.
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, Clinical efficacy and substantial 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 Aldeyra Therapeutics, Inc. on March 16, 2026.
NDA 216442 is the application under which FDA issued this complete response letter to Aldeyra Therapeutics, Inc.. The letter is dated March 16, 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.