Issued January 1, 2024
Issued
January 1, 2024
Application
Other • 215151
Review center
Other
Stage
Final Decision
Letter type
Approval Letter
This document is an 'Other Action Letter' from the FDA to an applicant regarding New Drug Application (NDA) 215151. It outlines deficiencies and required actions for the applicant to address within one year to move the application towards approval. Key areas of focus include labeling updates, proprietary name resubmission, and a comprehensive safety update.
The application received a Complete Response Letter due to significant deficiencies primarily related to the completeness and presentation of safety data, including the need for a comprehensive safety update, detailed adverse event reporting, and updated exposure information. Additionally, revisions to carton and container labeling and resubmission of the proprietary name are required.
Submit draft carton and container labeling based on FDA's proposed revisions dated November 22, 2022.
Recommended response: Revise carton and container labeling according to FDA's proposed revisions from November 22, 2022.
Resubmit the proposed proprietary name, Voquezna, when responding to application deficiencies. The name was previously found acceptable pending approval.
Recommended response: Include the proprietary name resubmission with the complete response to all deficiencies.
Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b), incorporating data from all nonclinical and clinical studies regardless of indication, dosage form, or dose level.
Recommended response: Prepare a comprehensive safety update adhering to 21 CFR 314.50(d)(5)(vi)(b), integrating all relevant nonclinical and clinical data.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
Describe in detail any significant changes or findings in the safety profile.
Recommended response: Analyze and document all significant changes or new findings in the safety profile, providing detailed descriptions.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
Incorporate new safety data into sections describing discontinuations due to adverse events, serious adverse events, and common adverse events. Present new data in the same format as original submission, tabulate new data combined with original, and compare frequencies.
Recommended response: Integrate new safety data into AE/SAE sections, ensuring consistent formatting, combined tabulations, and comparative frequency tables.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
For indications other than the proposed indication, provide separate tables for the frequencies of adverse events occurring in clinical trials.
Recommended response: Generate separate adverse event frequency tables for clinical trials related to indications other than the proposed one.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
Present a retabulation of the reasons for premature trial discontinuation by incorporating drop-outs from newly completed trials. Describe any new trends or patterns identified.
Recommended response: Update and retabulate reasons for premature trial discontinuations, including new trial data, and identify any emerging trends.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
Provide case report forms and narrative summaries for each subject who died during a clinical trial or did not complete a trial because of an adverse event. In addition, provide narrative summaries for serious adverse events.
Recommended response: Compile and submit all required case report forms and narrative summaries for deaths and serious adverse events.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
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.
Recommended response: Analyze and report any substantial changes in the incidence of common adverse events comparing new and original data.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
Provide updated exposure information for the clinical studies/trials (e.g., number of subjects, person time).
Recommended response: Submit updated clinical exposure data, including subject numbers and person-time, for all relevant studies.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
Provide a summary of worldwide experience on the safety of this drug, including an updated estimate of use for drug marketed in other countries.
Recommended response: Compile and submit a comprehensive summary of worldwide safety experience, including updated usage estimates from other markets.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
Provide English translations of current approved foreign labeling not previously submitted.
Recommended response: Submit English translations for all current approved foreign labeling that has not yet been provided.
The primary themes of the deficiencies are the need for a comprehensive and updated safety data package, including detailed adverse event reporting and worldwide experience, alongside necessary revisions to product labeling and proprietary name resubmission.
Regulatory change impact: Pending sponsor mitigation plan
Approval likelihood after response: 5%
Document viewer
Read the FDA letter and send context to the co-pilot at any time.