Source facts
FDA's complete response letter contains source-text evidence related to Nonclinical evidence, Safety and adverse events. 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
VANCOMYCIN — FDA Complete Response Letter (NDA 213895)
Issued to Xellia Pharmaceuticals, ApS. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 20, 2020Application
NDA 505b1 • 213895
Product
VANCOMYCIN
Company
Xellia Pharmaceuticals, ApS
Review center
Other
Stage
Final Decision
Response due
January 1, 2023
Assyro regulatory brief
FreeWhat did FDA decide for VANCOMYCIN?
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
- 1Nonclinical evidence: 6 source-text matches.
- 2Safety and adverse events: 5 source-text matches.
Nonclinical evidenceSafety and adverse events
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the VANCOMYCIN complete response letter
What does this complete response letter mean for VANCOMYCIN?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Xellia Pharmaceuticals, ApS on March 20, 2020.
What is NDA 213895?
NDA 213895 is the application under which FDA issued this complete response letter for VANCOMYCIN to Xellia Pharmaceuticals, ApS. It was reviewed by FDA Other. The letter is dated March 20, 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.