Issued to Regeneron Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 22, 2024Application
BLA • 761303
Product
Unknown
Company
Regeneron Pharmaceuticals, Inc.
Review center
CBERStage
Final Decision
Response due
March 22, 2025
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 Regeneron Pharmaceuticals, Inc. on March 22, 2024.
BLA 761303 is the application under which FDA issued this complete response letter for Unknown to Regeneron Pharmaceuticals, Inc.. It was reviewed by FDA CBER. The letter is dated March 22, 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.