Issued to Kala Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
August 7, 2019Application
NDA 505b1 • 210933
Product
EYSUVIS
Company
Kala Pharmaceuticals, Inc.
Review center
Other
Stage
Final Decision
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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 Kala Pharmaceuticals, Inc. on August 7, 2019.
NDA 210933 is the application under which FDA issued this complete response letter for EYSUVIS to Kala Pharmaceuticals, Inc.. It was reviewed by FDA Other. The letter is dated August 7, 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.