Complete Response Letter NDA 505b1 218317 (May 24, 2024)

Summary

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 218317. It outlines deficiencies identified during the review process, particularly concerning facility inspections, safety updates, and labeling, and provides instructions for a complete response and resubmission.

Key points

• The facility must provide satisfactory responses to deficiencies conveyed during pre-approval inspections to the FDA office indicated on form FDA-483 prior to the complete response to the application.
• The complete response must include the date(s) of the facility’s response to form FDA-483.
• The complete response must outline the corrections taken in response to the inspection.
• The applicant must work with the facility in resolving related deficiencies.
• The proposed proprietary name must be resubmitted when all application deficiencies identified in this letter have been addressed.
• A safety update must be included as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to the deficiencies.
• The safety update must describe in detail any significant changes or findings in the safety profile.
• The safety update must present new safety data from studies/clinical trials for the proposed indication using the same format as in the original submission.

Cited reasons

• Unresolved Facility Inspection Deficiencies
• Proprietary Name Resubmission Required
• Comprehensive Safety Update Requirements
• The application received a Complete Response Letter due to unresolved deficiencies from pre-approval facility inspections, the need to resubmit the proprietary name, and extensive requirements for a comprehensive safety update, including detailed clinical data, worldwide experience, and case narratives.

Recommended actions

• The facility must provide satisfactory responses to deficiencies conveyed during pre-approval inspections to the FDA office indicated on form FDA-483 prior to the complete response to the application.
• The complete response must include the date(s) of the facility’s response to form FDA-483.
• The complete response must outline the corrections taken in response to the inspection.
• The applicant must work with the facility in resolving related deficiencies.
• The proposed proprietary name must be resubmitted when all application deficiencies identified in this letter have been addressed.
• A safety update must be included as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to the deficiencies.
• The safety update must describe in detail any significant changes or findings in the safety profile.
• The safety update must present new safety data from studies/clinical trials for the proposed indication using the same format as in the original submission.

Deficiency summary

The application received a Complete Response Letter due to unresolved deficiencies from pre-approval facility inspections, the need to resubmit the proprietary name, and extensive requirements for a comprehensive safety update, including detailed clinical data, worldwide experience, and case narratives.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

NDA

Impact

Impact score

0.75

Estimated delay

240 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The application was not approved primarily due to unresolved manufacturing facility issues, requiring a resubmission of the proprietary name, and significant outstanding requirements for a comprehensive clinical safety data update.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%