Issued to Regeneron Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
August 20, 2024Application
BLA • 761400
Product
LYNOZYFIC
Company
Regeneron Pharmaceuticals, 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 Regeneron Pharmaceuticals, Inc. on August 20, 2024.
BLA 761400 is the application under which FDA issued this complete response letter for LYNOZYFIC to Regeneron Pharmaceuticals, Inc.. The letter is dated August 20, 2024.
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.