Complete Response Letter NDA 505b1 210168 (Jun 20, 2025)

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 reserves comment on proposed labeling until the application is otherwise adequate and outlines required actions for the applicant within one year, including resubmission or withdrawal, and emphasizes that the drug cannot be marketed until approved.

Key points

• The applicant must review labeling review resources on the Prescription Drug Labeling Resources and Pregnancy and Lactation Labeling Final Rule websites.
• The applicant must resubmit or take other actions available under 21 CFR 314.110 within one year after the date of this letter.
• If the applicant does not take one of the specified actions, the FDA may consider the lack of response a request to withdraw the application 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 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 must clearly state that the applicant considers it a complete response to the outlined deficiencies.
• A partial response to this letter will not be processed as a resubmission and will not start a new review cycle.

Cited reasons

• Inadequate Proposed Labeling
• The application is not approvable due to inadequate proposed labeling, including prescribing information, carton, and container labeling. The agency reserves full comment on labeling until the application is otherwise adequate.

Recommended actions

• The applicant must review labeling review resources on the Prescription Drug Labeling Resources and Pregnancy and Lactation Labeling Final Rule websites.
• The applicant must resubmit or take other actions available under 21 CFR 314.110 within one year after the date of this letter.
• If the applicant does not take one of the specified actions, the FDA may consider the lack of response a request to withdraw the application 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 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 must clearly state that the applicant considers it a complete response to the outlined deficiencies.
• A partial response to this letter will not be processed as a resubmission and will not start a new review cycle.

Deficiency summary

The application is not approvable due to inadequate proposed labeling, including prescribing information, carton, and container labeling. The agency reserves full comment on labeling until the application is otherwise adequate.

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 reason for the Complete Response Letter is the inadequacy of the proposed labeling, which prevents the application from being approved. Further action is required by the sponsor within one year.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%