Approval Letter Other 215352 (Jan 1, 2023)

Summary

This document is an 'Other Action Letter' from the FDA regarding NDA 215352. It outlines deficiencies and provides guidance on various aspects including human factors validation, prescribing information, carton and container labeling, proprietary name, and safety updates. It also specifies the actions required for resubmission and the timeline for response.

Key points

• Review labeling review resources on the Prescription Drug Labeling Resources and Pregnancy and Lactation Labeling Final Rule websites, including regulations and related guidance documents.
• Use the Selected Requirements for Prescribing Information (SRPI) checklist to ensure Prescribing Information conforms with format items in regulations and guidances if labeling is revised.
• Include updated content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format if labeling is revised.
• Resubmit the proposed proprietary name (MYDCOMBI) when responding to the application deficiencies.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies, including data from all nonclinical and clinical studies/trials of the drug under consideration regardless of indication, dosage form, or dose level.
• Resubmit the application or take other actions available under 21 CFR 314.110 within one year after the date of this letter.
• If resubmitting, fully address all deficiencies listed in this letter.
• Mark any resubmission with 'RESUBMISSION' in large font, bolded type at the beginning of the cover letter.

Cited reasons

• Proprietary Name Resubmission Required
• Safety Update Required
• Prescribing Information and Labeling Comments Reserved
• The application received a Complete Response Letter due to deficiencies related to the proprietary name resubmission, the requirement for a comprehensive safety update, and pending comments on prescribing information and labeling. The proposed proprietary name was found acceptable pending approval, but needs to be resubmitted with the complete response. A safety update covering all nonclinical and clinical data is mandated per 21 CFR 314.50(d)(5)(vi)(b). Comments on labeling are reserved until other deficiencies are addressed, but the sponsor is advised to prepare updated content in SPL format.

Recommended actions

• Review labeling review resources on the Prescription Drug Labeling Resources and Pregnancy and Lactation Labeling Final Rule websites, including regulations and related guidance documents.
• Use the Selected Requirements for Prescribing Information (SRPI) checklist to ensure Prescribing Information conforms with format items in regulations and guidances if labeling is revised.
• Include updated content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format if labeling is revised.
• Resubmit the proposed proprietary name (MYDCOMBI) when responding to the application deficiencies.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies, including data from all nonclinical and clinical studies/trials of the drug under consideration regardless of indication, dosage form, or dose level.
• Resubmit the application or take other actions available under 21 CFR 314.110 within one year after the date of this letter.
• If resubmitting, fully address all deficiencies listed in this letter.
• Mark any resubmission with 'RESUBMISSION' in large font, bolded type at the beginning of the cover letter.

Deficiency summary

The application received a Complete Response Letter due to deficiencies related to the proprietary name resubmission, the requirement for a comprehensive safety update, and pending comments on prescribing information and labeling. The proposed proprietary name was found acceptable pending approval, but needs to be resubmitted with the complete response. A safety update covering all nonclinical and clinical data is mandated per 21 CFR 314.50(d)(5)(vi)(b). Comments on labeling are reserved until other deficiencies are addressed, but the sponsor is advised to prepare updated content in SPL format.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

Unknown

Impact

Impact score

0.75

Estimated delay

365 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The primary themes of the Complete Response Letter are administrative compliance for proprietary name resubmission, a critical requirement for a comprehensive safety data update, and proactive preparation for labeling compliance, all of which are necessary for eventual approval.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%