Issued to Corcept Therapeutics. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 28, 2026Application
NDA 505b1 • 219398
Product
NDA 219398
Company
Corcept Therapeutics
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, Safety and adverse events, Statistical analysis. 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 Corcept Therapeutics on January 28, 2026.
NDA 219398 is the application under which FDA issued this complete response letter to Corcept Therapeutics. The letter is dated January 28, 2026.
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.