Source facts
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. 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
Unknown — FDA Complete Response Letter (BLA 761393)
Issued to Seikagaku Corporation. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 11, 2025Application
BLA • 761393
Product
Unknown
Company
Seikagaku Corporation
Review center
CBERStage
Final Decision
Response due
March 11, 2026
Assyro regulatory brief
FreeWhat did FDA decide for Unknown?
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Key details in this letter
- 1Labeling, packaging, and proprietary name: 11 source-text matches.
Labeling, packaging, and proprietary name
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the Unknown complete response letter
What does this complete response letter mean for Unknown?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Seikagaku Corporation on March 11, 2025.
What is BLA 761393?
BLA 761393 is the application under which FDA issued this complete response letter for Unknown to Seikagaku Corporation. It was reviewed by FDA CBER. The letter is dated March 11, 2025.
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.