Complete Response Letter NDA 505b1 214610 (Dec 11, 2024)

Summary

This document is a communication from the U.S. Food and Drug Administration (FDA) regarding New Drug Application (NDA) 214610. It outlines specific requirements related to product quality, prescribing information, and safety data, and provides instructions for resubmission or further actions.

Key points

• Review labeling review resources on the Prescription Drug Labeling Resources and Pregnancy and Lactation Labeling Final Rule websites, including regulations, guidance documents, and the Selected Requirements for Prescribing Information (SRPI).
• Describe any information that suggests a substantial change in the incidence of common, but less serious, adverse events between the new data and the original application data.
• Provide updated exposure information for the clinical studies/trials (e.g., number of subjects, person time).
• Provide a summary of worldwide experience on the safety of this drug, including an updated estimate of use for drug marketed in other countries.
• Provide English translations of current approved foreign labeling not previously submitted.
• Resubmit the application or take other actions available under 21 CFR 314.110 within one year after the date of this letter.
• Clearly mark any resubmission with 'RESUBMISSION' in large font, bolded type at the beginning of the cover letter.
• Ensure the cover letter for a resubmission clearly states that it is considered a complete response to the deficiencies outlined in this letter.

Cited reasons

• Adverse Event Incidence Change Analysis
• Updated Clinical Exposure Information
• Worldwide Safety Experience and Usage Estimate
• Foreign Labeling Translations
• The application lacks sufficient updated clinical exposure and safety data, including a comprehensive worldwide safety summary and an analysis of adverse event incidence changes. Additionally, English translations of all current approved foreign labeling are required.

Recommended actions

• Review labeling review resources on the Prescription Drug Labeling Resources and Pregnancy and Lactation Labeling Final Rule websites, including regulations, guidance documents, and the Selected Requirements for Prescribing Information (SRPI).
• Describe any information that suggests a substantial change in the incidence of common, but less serious, adverse events between the new data and the original application data.
• Provide updated exposure information for the clinical studies/trials (e.g., number of subjects, person time).
• Provide a summary of worldwide experience on the safety of this drug, including an updated estimate of use for drug marketed in other countries.
• Provide English translations of current approved foreign labeling not previously submitted.
• Resubmit the application or take other actions available under 21 CFR 314.110 within one year after the date of this letter.
• Clearly mark any resubmission with 'RESUBMISSION' in large font, bolded type at the beginning of the cover letter.
• Ensure the cover letter for a resubmission clearly states that it is considered a complete response to the deficiencies outlined in this letter.

Deficiency summary

The application lacks sufficient updated clinical exposure and safety data, including a comprehensive worldwide safety summary and an analysis of adverse event incidence changes. Additionally, English translations of all current approved foreign labeling are required.

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 themes are insufficient clinical data completeness and global safety reporting, along with administrative deficiencies related to foreign labeling documentation.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%