Issued to NeuroDerm, Ltd.. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 21, 2025Application
NDA 505b1 • 218317
Product
NDA 218317
Company
NeuroDerm, Ltd.
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, Nonclinical evidence. 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 NeuroDerm, Ltd. on October 21, 2025.
NDA 218317 is the application under which FDA issued this complete response letter to NeuroDerm, Ltd.. The letter is dated October 21, 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.