Approval Letter Other 214439 (Jan 1, 2022)

Summary

This is a Complete Response Letter from the FDA to CMP Development LLC regarding their New Drug Application (NDA) for NORLIQVA (amlodipine) Oral Solution 1 mg/mL. The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections, proprietary name resubmission, and required safety updates.

Key points

• Satisfactorily resolve deficiencies identified during recent inspections of manufacturing facilities.
• Satisfactorily resolve objectionable conditions noted during a review of records from a manufacturing facility, potentially requiring a preapproval inspection and adequate facility responses.
• Ensure an inspection of a specific facility is completed and its ability to conduct listed manufacturing operations is assessed by the FDA.
• Resubmit the proposed proprietary name, NORLIQVA, when responding to the application deficiencies.
• Include a comprehensive safety update as described in 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• The safety update must describe significant changes or findings in the safety profile.
• The safety update must present new safety data from studies/clinical trials for the proposed indication in the same format as the original submission.
• The safety update must present tabulations of new safety data combined with original application data.

Cited reasons

• Unresolved Manufacturing Facility Deficiencies
• Proprietary Name Resubmission Required
• Inadequate Safety Update and Data Presentation
• The application cannot be approved in its current form due to unresolved manufacturing facility deficiencies, the need to resubmit the proprietary name, and extensive requirements for a comprehensive safety update including detailed data presentation and worldwide experience.

Recommended actions

• Satisfactorily resolve deficiencies identified during recent inspections of manufacturing facilities.
• Satisfactorily resolve objectionable conditions noted during a review of records from a manufacturing facility, potentially requiring a preapproval inspection and adequate facility responses.
• Ensure an inspection of a specific facility is completed and its ability to conduct listed manufacturing operations is assessed by the FDA.
• Resubmit the proposed proprietary name, NORLIQVA, when responding to the application deficiencies.
• Include a comprehensive safety update as described in 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• The safety update must describe significant changes or findings in the safety profile.
• The safety update must present new safety data from studies/clinical trials for the proposed indication in the same format as the original submission.
• The safety update must present tabulations of new safety data combined with original application data.

Deficiency summary

The application cannot be approved in its current form due to unresolved manufacturing facility deficiencies, the need to resubmit the proprietary name, and extensive requirements for a comprehensive safety update including detailed data presentation and worldwide experience.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

505(b)(2)

Impact

Impact score

0.95

Estimated delay

545 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The application received a Complete Response Letter primarily due to critical manufacturing compliance issues, insufficient and incomplete safety data updates, and administrative requirements related to proprietary name resubmission. Resolution of these issues, particularly manufacturing and comprehensive safety data, is essential for approval.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%