Issued to Janssen Biotech, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 13, 2024Application
BLA • 761433
Product
RYBREVANT FASPRO
Company
Janssen Biotech, Inc.
Review center
CBERStage
Final Decision
Response due
December 13, 2025
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 Janssen Biotech, Inc. on December 13, 2024.
BLA 761433 is the application under which FDA issued this complete response letter for RYBREVANT FASPRO to Janssen Biotech, Inc.. It was reviewed by FDA CBER. The letter is dated December 13, 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.