Issued to Tris Pharma, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 15, 2026Application
NDA 505b1 • 220138
Product
NDA 220138
Company
Tris Pharma, Inc.
Stage
Final Decision
Assyro regulatory brief
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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, Bioequivalence and pharmacokinetics. 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 Tris Pharma, Inc. on June 15, 2026.
NDA 220138 is the application under which FDA issued this complete response letter to Tris Pharma, Inc.. The letter is dated June 15, 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.