Issued to Ocuvex Therapeutics, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 15, 2026Application
NDA 505b1 • 217363
Product
NDA 217363
Company
Ocuvex 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, 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 Ocuvex Therapeutics, Inc. on May 15, 2026.
NDA 217363 is the application under which FDA issued this complete response letter to Ocuvex Therapeutics, Inc.. The letter is dated May 15, 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.