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
LOPRESSOR — FDA Complete Response Letter (NDA 218698)
Issued to XTM Consulting LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 12, 2024Application
NDA 505b1 • 218698
Product
LOPRESSOR
Company
XTM Consulting LLC
Review center
CDERStage
Final Decision
Response due
June 12, 2025
Assyro regulatory brief
FreeWhat did FDA decide for LOPRESSOR?
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
- 1Labeling, packaging, and proprietary name: 10 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 LOPRESSOR complete response letter
What does this complete response letter mean for LOPRESSOR?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to XTM Consulting LLC on June 12, 2024.
What is NDA 218698?
NDA 218698 is the application under which FDA issued this complete response letter for LOPRESSOR to XTM Consulting LLC. It was reviewed by FDA CDER. The letter is dated June 12, 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.