Approval Letter Other 213218 (Jan 1, 2022)

Summary

This letter from the FDA's Center for Drug Evaluation and Research addresses an applicant regarding deficiencies in application number 213218Orig1s000. It requests the submission of draft carton and container labeling, resubmission of the proposed proprietary name, and a comprehensive safety update. The safety update must include detailed new safety data from clinical studies, comparisons with original data, retabulation of trial discontinuations, case report forms for adverse events, updated exposure information, a summary of worldwide safety experience, and English translations of foreign labeling. The applicant is required to resubmit or take other actions within one year, fully addressing all deficiencies, or the application may be considered withdrawn. The drug cannot be marketed until approved.

Key points

• Submit draft carton and container labeling.
• Resubmit the proposed proprietary name, SOAAANZ, which was conditionally acceptable.
• Include a safety update as described at 21 CFR 314.50(g)(5)(vi)(b).
• Describe in detail any significant changes or findings in the safety profile within the safety update.
• 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/clinical trials for the proposed indication using the same format as in the original submission.
• Present tabulations of the new safety data combined with the original application data.
• Include tables that compare frequencies of adverse events in the original application with the retabulated frequencies.

Cited reasons

• Carton and Container Labeling
• Proprietary Name Resubmission
• Comprehensive Safety Update
• The application received a Complete Response Letter due to deficiencies primarily related to incomplete carton and container labeling, the need for resubmission of the proprietary name, and critical gaps in the comprehensive safety update, including insufficient nonclinical and clinical data analysis, adverse event reporting, and worldwide safety experience.

Recommended actions

• Submit draft carton and container labeling.
• Resubmit the proposed proprietary name, SOAAANZ, which was conditionally acceptable.
• Include a safety update as described at 21 CFR 314.50(g)(5)(vi)(b).
• Describe in detail any significant changes or findings in the safety profile within the safety update.
• 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/clinical trials for the proposed indication using the same format as in the original submission.
• Present tabulations of the new safety data combined with the original application data.
• Include tables that compare frequencies of adverse events in the original application with the retabulated frequencies.

Deficiency summary

The application received a Complete Response Letter due to deficiencies primarily related to incomplete carton and container labeling, the need for resubmission of the proprietary name, and critical gaps in the comprehensive safety update, including insufficient nonclinical and clinical data analysis, adverse event reporting, and worldwide safety experience.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

NDA

Impact

Impact score

0.95

Estimated delay

545 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The primary themes for the complete response are insufficient labeling information and critical gaps in the safety data update, which are fundamental requirements for drug approval.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%