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
TYENNE — FDA Complete Response Letter (BLA 761275)
Issued to Fresenius Kabi USA, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 31, 2023Application
BLA • 761275
Product
TYENNE
Company
Fresenius Kabi USA, LLC
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
Assyro regulatory brief
FreeWhat did FDA decide for TYENNE?
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Key details in this letter
- 1Labeling, packaging, and proprietary name: 17 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 TYENNE complete response letter
What does this complete response letter mean for TYENNE?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Fresenius Kabi USA, LLC on May 31, 2023.
What is BLA 761275?
BLA 761275 is the application under which FDA issued this complete response letter for TYENNE to Fresenius Kabi USA, LLC. It was reviewed by FDA Other. The letter is dated May 31, 2023.
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.