Issued to Outlook Therapeutics, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 30, 2025Application
BLA • 761320
Product
LYTENAVA
Company
Outlook Therapeutics, 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. 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 Outlook Therapeutics, Inc. on December 30, 2025.
BLA 761320 is the application under which FDA issued this complete response letter for LYTENAVA to Outlook Therapeutics, Inc.. The letter is dated December 30, 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.