Source facts
FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
US FDA source recordCRL · Complete Response Letter
VYLOY — FDA Complete Response Letter (BLA 761365)
Issued to Astellas Pharma US, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 4, 2024Application
BLA • 761365
Product
VYLOY
Company
Astellas Pharma US, Inc.
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
Assyro regulatory brief
FreeWhat did FDA decide for VYLOY?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1Facility inspection and CGMP compliance: 3 source-text matches.
Facility inspection and CGMP compliance
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the VYLOY complete response letter
What does this complete response letter mean for VYLOY?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Astellas Pharma US, Inc. on January 4, 2024.
What is BLA 761365?
BLA 761365 is the application under which FDA issued this complete response letter for VYLOY to Astellas Pharma US, Inc.. It was reviewed by FDA Other. The letter is dated January 4, 2024.
What happens after an FDA complete response letter?
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.