Issued to Eyenovia, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 22, 2021Application
NDA 505b1 • 215352
Product
MYDCOMBI
Company
Eyenovia, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2024
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Facility inspection and CGMP compliance, Safety and adverse events. 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 Eyenovia, Inc. on October 22, 2021.
NDA 215352 is the application under which FDA issued this complete response letter for MYDCOMBI to Eyenovia, Inc.. It was reviewed by FDA Other. The letter is dated October 22, 2021.
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.