Issued to Achieve Life Sciences, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 20, 2026Application
NDA 505b1 • 218995
Product
NDA 218995
Company
Achieve Life Sciences, 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, Facility inspection and CGMP compliance. 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 Achieve Life Sciences, Inc. on June 20, 2026.
NDA 218995 is the application under which FDA issued this complete response letter to Achieve Life Sciences, Inc.. The letter is dated June 20, 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.