Issued to Disc Medicine, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 13, 2026Application
NDA 505b1 • 220707
Product
NDA 220707
Company
Disc Medicine, Inc.
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. 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 Disc Medicine, Inc. on February 13, 2026.
NDA 220707 is the application under which FDA issued this complete response letter to Disc Medicine, Inc.. The letter is dated February 13, 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.