Complete Response Letter NDA 505b1 218923 (Jul 30, 2025)

Summary

This FDA letter addresses deficiencies in NDA 218923, reserving comment on proposed labeling and proprietary name until the application is otherwise adequate. It mandates a comprehensive safety update, including detailed data presentation, and outlines specific requirements for resubmission within one year, emphasizing that a partial response will not be processed.

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).
• Resubmit the proposed proprietary name when responding to all application deficiencies.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• The safety update must include data from all nonclinical and clinical studies of the drug under consideration regardless of indication, dosage form, or dose level.
• Describe in detail any significant changes or findings in the safety profile.
• Incorporate new safety data into sections describing discontinuations due to adverse events, serious adverse events, and common adverse events.
• Present new safety data from studies for the proposed indication using the same format as in the original submission.
• Present tabulations of new safety data combined with the original application data.

Cited reasons

• Inadequate Safety Update and Clinical Data Presentation
• Missing English Translations of Foreign Labeling
• Proprietary Name Resubmission Required
• The application received a Complete Response due to significant deficiencies primarily related to the safety update, including inadequate presentation of new clinical safety data, missing case report forms and narrative summaries for serious adverse events and deaths, and lack of comprehensive worldwide safety experience. Additionally, English translations of foreign labeling were not provided, and the proprietary name requires resubmission with the complete response.

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).
• Resubmit the proposed proprietary name when responding to all application deficiencies.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• The safety update must include data from all nonclinical and clinical studies of the drug under consideration regardless of indication, dosage form, or dose level.
• Describe in detail any significant changes or findings in the safety profile.
• Incorporate new safety data into sections describing discontinuations due to adverse events, serious adverse events, and common adverse events.
• Present new safety data from studies for the proposed indication using the same format as in the original submission.
• Present tabulations of new safety data combined with the original application data.

Deficiency summary

The application received a Complete Response due to significant deficiencies primarily related to the safety update, including inadequate presentation of new clinical safety data, missing case report forms and narrative summaries for serious adverse events and deaths, and lack of comprehensive worldwide safety experience. Additionally, English translations of foreign labeling were not provided, and the proprietary name requires resubmission with the complete response.

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 inadequacy and incompleteness of the safety data package, particularly concerning the presentation of clinical safety information and global safety experience. There are also administrative issues related to foreign labeling and proprietary name resubmission.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%