Complete Response Letter NDA 505b1 210168 (Mar 22, 2024)

Summary

This document is a letter from the U.S. Food and Drug Administration (FDA) to an applicant regarding New Drug Application (NDA) 210168. It outlines the required actions for the applicant to take within one year, primarily focusing on resubmission or other actions under 21 CFR 314.110, and details the proper format and content for a resubmission. It also mentions the option to request a meeting with the FDA.

Key points

• Resubmit or take other actions available under 22 CFR 314.110 within one year after the date of this letter.
• Fully address all deficiencies listed in this letter in any resubmission.
• Clearly mark any resubmission with 'RESUBMISSION' in large font, bolded type at the beginning of the cover letter.
• The cover letter of a resubmission must clearly state that it is considered a complete response to the outlined deficiencies.
• Submit a meeting request as described in the draft guidance 'Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products' if a meeting or teleconference is desired.
• Respond to agency requests within the prescribed timeline.

Cited reasons

• Agency deficiencies
• A Complete Response Letter has been issued, indicating that the application cannot be approved in its present form. The letter requires the applicant to fully address all deficiencies listed in the complete letter (not provided in this excerpt) for resubmission.

Recommended actions

• Resubmit or take other actions available under 22 CFR 314.110 within one year after the date of this letter.
• Fully address all deficiencies listed in this letter in any resubmission.
• Clearly mark any resubmission with 'RESUBMISSION' in large font, bolded type at the beginning of the cover letter.
• The cover letter of a resubmission must clearly state that it is considered a complete response to the outlined deficiencies.
• Submit a meeting request as described in the draft guidance 'Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products' if a meeting or teleconference is desired.

Deficiency summary

A Complete Response Letter has been issued, indicating that the application cannot be approved in its present form. The letter requires the applicant to fully address all deficiencies listed in the complete letter (not provided in this excerpt) for resubmission.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

NDA

Impact

Impact score

0.75

Estimated delay

365 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The primary theme is the need for the applicant to address outstanding deficiencies to achieve approval. The agency emphasizes the requirement for a comprehensive resubmission and offers a meeting to discuss the necessary steps.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%