Issued to Vyluma, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
August 27, 2025Application
NDA 505b1 • 217711
Product
NDA 217711
Company
Vyluma, Inc.
Stage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, 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 Vyluma, Inc. on August 27, 2025.
NDA 217711 is the application under which FDA issued this complete response letter to Vyluma, Inc.. The letter is dated August 27, 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.