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
FEXINIDAZOLE — FDA Complete Response Letter (NDA 214429)
Issued to sanofi-aventis U.S. LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
November 12, 2020Application
NDA 505b1 • 214429
Product
FEXINIDAZOLE
Company
sanofi-aventis U.S. LLC
Review center
Other
Stage
Final Decision
Response due
January 1, 2022
Assyro regulatory brief
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Key details in this letter
- 1Labeling, packaging, and proprietary name: 22 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 FEXINIDAZOLE complete response letter
What does this complete response letter mean for FEXINIDAZOLE?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to sanofi-aventis U.S. LLC on November 12, 2020.
What is NDA 214429?
NDA 214429 is the application under which FDA issued this complete response letter for FEXINIDAZOLE to sanofi-aventis U.S. LLC. It was reviewed by FDA Other. The letter is dated November 12, 2020.
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.