Issued to Bausch Health Ireland Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 19, 2019Application
NDA 505b1 • 211039
Product
FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE
Company
Bausch Health Ireland Limited
Review center
Other
Stage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, Safety and adverse events, Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name. 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 Bausch Health Ireland Limited on July 19, 2019.
NDA 211039 is the application under which FDA issued this complete response letter for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE to Bausch Health Ireland Limited. It was reviewed by FDA Other. The letter is dated July 19, 2019.
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.