Approval Letter Other 214522 (Jan 1, 2023)

Summary

This letter from the FDA's Center for Drug Evaluation and Research informs the applicant of NDA 214522 about required actions following an initial review. It outlines the process for resubmission or other actions, emphasizing the need to address all deficiencies and the consequences of inaction. It also provides guidance on requesting meetings and clarifies that the drug cannot be marketed until approved.

Key points

• The applicant is required to resubmit or take other actions available under 21 CFR 314.110 within one year after the date of this letter.
• Failure to take action may result in the application being considered withdrawn under 21 CFR 314.65.
• The applicant may request an extension of time to resubmit the application.
• A resubmission must fully address all deficiencies listed in the letter.
• A resubmission must be clearly marked with 'RESUBMISSION' in large font, bolded type at the beginning of the cover letter.
• The cover letter for a resubmission should clearly state that it is considered a complete response to the outlined deficiencies.
• A partial response will not be processed as a resubmission and will not start a new review cycle.
• The applicant may request a meeting or teleconference to discuss the steps needed for approval.

Cited reasons

• Agency deficiencies
• The application is not approvable in its current form. A full resubmission addressing all identified deficiencies is required. Specific deficiencies are not detailed in the provided text.

Recommended actions

• The applicant is required to resubmit or take other actions available under 21 CFR 314.110 within one year after the date of this letter.
• Failure to take action may result in the application being considered withdrawn under 21 CFR 314.65.
• The applicant may request an extension of time to resubmit the application.
• A resubmission must fully address all deficiencies listed in the letter.
• A resubmission must be clearly marked with 'RESUBMISSION' in large font, bolded type at the beginning of the cover letter.
• The cover letter for a resubmission should clearly state that it is considered a complete response to the outlined deficiencies.
• A partial response will not be processed as a resubmission and will not start a new review cycle.
• The applicant may request a meeting or teleconference to discuss the steps needed for approval.

Deficiency summary

The application is not approvable in its current form. A full resubmission addressing all identified deficiencies is required. Specific deficiencies are not detailed in the provided text.

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 application requires a comprehensive resubmission to address all identified deficiencies, as it is not approvable in its current state. The sponsor has one year to resubmit or take other actions.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%