Complete Response Letters
Ocuvex Therapeutics, Inc.: brimonidine tartrate
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, May 15, 2026
November 18, 2025, which constituted a complete response to our July 11, 2023, action letter.
CRL_NDA217363_20260515:p1:s13The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response.
CRL_NDA217363_20260515:p1:s19The facility's satisfactory responses are dependent on FDA's determination that the facility has come into compliance with CGMP and may require re-inspection of the facility.
CRL_NDA217363_20260515:p1:s20FDA may need to conduct a PAI of the facility.
CRL_NDA217363_20260515:p1:s24Satisfactory outcomes of both the PAI and the CGMP surveillance inspections will be needed prior to an approval of the application.
CRL_NDA217363_20260515:p1:s25More Complete Response Letters
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.