Approval Letter Other (Nov 13, 2025)

Summary

The FDA issued Complete Response letters for New Drug Applications (NDAs) 212887 (VOCABRIA) and 212888 (CABENUVA) from ViiV Healthcare Company, indicating that neither application can be approved in its current form due to various deficiencies. Approval of VOCABRIA is contingent on CABENUVA's approval.

Key points

• Address product quality deficiencies identified in the CABENUVA NDA, as VOCABRIA's approval is contingent on CABENUVA's approval.
• Satisfactorily resolve deficiencies identified during the inspection of the GLAXO OPERATIONS UK LIMITED manufacturing facility and include updates in the resubmission.
• Ensure the referenced Drug Master File (DMF) is adequately addressed by the DMF holder and provide the date of amendment.
• Review and revise proposed labeling to conform with PLR Requirements for Prescribing Information, including regulations and guidance documents, utilizing the SRPI checklist.
• Submit updated content of labeling in Structured Product Labeling (SPL) format as described at FDA.gov [21 CFR 314.50(l)(1)(i)].
• Provide a highlighted or marked-up copy showing all labeling changes, along with a clean Microsoft Word version, including annotations.
• Submit the latest draft carton and container labeling.
• Resubmit the proposed proprietary names (VOCABRIA and CABENUVA) when responding to the application deficiencies.

Cited reasons

• Approval Contingent on CABENUVA NDA
• Prescribing Information Not Finalized
• Carton and Container Labeling Update Required
• Proprietary Name Resubmission Required
• Comprehensive Safety Update Required
• Approval of VOCABRIA is contingent on the approval of the CABENUVA NDA, which has unresolved product quality deficiencies. Additionally, the application requires updates to labeling, resubmission of the proprietary name, and a comprehensive safety update.

Recommended actions

• Address product quality deficiencies identified in the CABENUVA NDA, as VOCABRIA's approval is contingent on CABENUVA's approval.
• Satisfactorily resolve deficiencies identified during the inspection of the GLAXO OPERATIONS UK LIMITED manufacturing facility and include updates in the resubmission.
• Ensure the referenced Drug Master File (DMF) is adequately addressed by the DMF holder and provide the date of amendment.
• Review and revise proposed labeling to conform with PLR Requirements for Prescribing Information, including regulations and guidance documents, utilizing the SRPI checklist.
• Submit updated content of labeling in Structured Product Labeling (SPL) format as described at FDA.gov [21 CFR 314.50(l)(1)(i)].
• Provide a highlighted or marked-up copy showing all labeling changes, along with a clean Microsoft Word version, including annotations.
• Submit the latest draft carton and container labeling.
• Resubmit the proposed proprietary names (VOCABRIA and CABENUVA) when responding to the application deficiencies.

Deficiency summary

Approval of VOCABRIA is contingent on the approval of the CABENUVA NDA, which has unresolved product quality deficiencies. Additionally, the application requires updates to labeling, resubmission of the proprietary name, and a comprehensive safety update.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

NDA 505(b)

Impact

Impact score

0.95

Estimated delay

545 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

Approval is withheld due to critical dependencies on a linked NDA (CABENUVA) and requires a comprehensive safety update, along with standard labeling and administrative updates for VOCABRIA.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%