Issued to Saol International Development Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
August 27, 2025Application
NDA 505b1 • 218679
Product
NDA 218679
Company
Saol International Development Limited
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, Statistical analysis, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Saol International Development Limited on August 27, 2025.
NDA 218679 is the application under which FDA issued this complete response letter to Saol International Development Limited. The letter is dated August 27, 2025.
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.