Complete Response Letter NDA 505b1 217719 (Mar 10, 2025)

Summary

This section outlines the required actions for an applicant following an FDA letter regarding NDA 217719, including deadlines for resubmission or other actions, specific formatting for resubmissions, and conditions for product distribution.

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 one of these actions may result in the FDA considering the lack of response a request to withdraw the application under 21 CFR 314.65.
• A resubmission must fully address all deficiencies listed in this letter.
• A resubmission must be clearly marked with "RESUBMISSION" in large font, bolded type at the beginning of the cover letter.
• The cover letter of a resubmission should clearly state that the applicant considers it 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 product may not be distributed until the applicant has been notified in writing that this application is tentatively approved.
• Respond to agency requests within the prescribed timeline.

Cited reasons

• Agency deficiencies
• The application is not ready for approval and requires a full resubmission addressing all deficiencies. Specific deficiencies are not detailed in the provided letter excerpt, but a complete response is mandated to avoid withdrawal of the application.

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 one of these actions may result in the FDA considering the lack of response a request to withdraw the application under 21 CFR 314.65.
• A resubmission must fully address all deficiencies listed in this letter.
• A resubmission must be clearly marked with "RESUBMISSION" in large font, bolded type at the beginning of the cover letter.
• The cover letter of a resubmission should clearly state that the applicant considers it 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 product may not be distributed until the applicant has been notified in writing that this application is tentatively approved.

Deficiency summary

The application is not ready for approval and requires a full resubmission addressing all deficiencies. Specific deficiencies are not detailed in the provided letter excerpt, but a complete response is mandated to avoid withdrawal of the application.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

NDA

Impact

Impact score

0.75

Estimated delay

180 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The FDA issued a Complete Response Letter for NDA 217719, indicating the application is not approvable in its current form. A full resubmission addressing all deficiencies is required within one year, or the application may be withdrawn. The letter also offers the option for a meeting to discuss the necessary steps for approval, referencing relevant guidance for formal meetings.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%