Source facts
FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance. 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
CABENUVA KIT / VOCABRIA — FDA Complete Response Letter (NDA 212888)
Issued to ViiV Healthcare Company. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 19, 2019Application
NDA 505b1 • 212888
Product
CABENUVA KIT / VOCABRIA
Company
ViiV Healthcare Company
Review center
Other
Stage
Final Decision
Response due
November 13, 2026
Assyro regulatory brief
FreeWhat did FDA decide for CABENUVA KIT / VOCABRIA?
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Key details in this letter
- 1Facility inspection and CGMP compliance: 2 source-text matches.
Facility inspection and CGMP compliance
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the CABENUVA KIT / VOCABRIA complete response letter
What does this complete response letter mean for CABENUVA KIT / VOCABRIA?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to ViiV Healthcare Company on December 19, 2019.
What is NDA 212888?
NDA 212888 is the application under which FDA issued this complete response letter for CABENUVA KIT / VOCABRIA to ViiV Healthcare Company. It was reviewed by FDA Other. The letter is dated December 19, 2019.
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.