Complete Response Letter NDA 505b1 218524 (Mar 29, 2024)

Summary

This FDA letter communicates deficiencies in New Drug Application (NDA) 218524, primarily concerning prescribing information (PI) and safety updates. It outlines specific requirements for revising labeling, submitting safety data, and the process for resubmission or other actions within one year.

Key points

• Submit draft labeling responsive to the FDA's electronic communication.
• Use the SRPI checklist to correct any formatting errors in the labeling to ensure conformance with regulations and guidances.
• Submit updated content of labeling in Structured Product Labeling (SPL) format as described at FDA.gov, in accordance with 21 CFR 314.50(l)(1)(i).
• Provide a highlighted or marked-up copy showing all changes, along with a clean Word version, for proposed labeling changes.
• Ensure the proposed Prescribing Information (PI) conforms to the content and format regulations found at 21 CFR 201.56(a) and (d) and 201.57.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• 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.

Cited reasons

• Prescribing Information Content and Format Deficiencies
• Inadequate Safety Update
• The FDA issued a Complete Response Letter for NDA 218524, citing significant deficiencies primarily related to the Prescribing Information (PI) content and format, and the inadequacy of the safety update. The proposed PI does not conform to regulatory requirements, and a comprehensive safety update incorporating all nonclinical and clinical data is required.

Recommended actions

• Submit draft labeling responsive to the FDA's electronic communication.
• Use the SRPI checklist to correct any formatting errors in the labeling to ensure conformance with regulations and guidances.
• Submit updated content of labeling in Structured Product Labeling (SPL) format as described at FDA.gov, in accordance with 21 CFR 314.50(l)(1)(i).
• Provide a highlighted or marked-up copy showing all changes, along with a clean Word version, for proposed labeling changes.
• Ensure the proposed Prescribing Information (PI) conforms to the content and format regulations found at 21 CFR 201.56(a) and (d) and 201.57.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• 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.

Deficiency summary

The FDA issued a Complete Response Letter for NDA 218524, citing significant deficiencies primarily related to the Prescribing Information (PI) content and format, and the inadequacy of the safety update. The proposed PI does not conform to regulatory requirements, and a comprehensive safety update incorporating all nonclinical and clinical data is 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 of the Complete Response Letter are non-compliance with labeling content and format regulations, and the need for a comprehensive and updated safety data submission.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%