Approval Letter Other 214429 (Jan 1, 2021)

Summary

The FDA issued a Complete Response letter for NDA 214429 for Fexinidazole tablets, indicating that the application cannot be approved in its current form due to deficiencies primarily related to product labeling and the need for an updated safety profile.

Key points

• Submit draft labeling that addresses the FDA's proposed revisions communicated via email on November 4, 2020.
• 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, per 21 CFR 314.50(l)(1)(i).
• Provide a highlighted or marked-up copy showing all changes, with annotations, and a clean Word version of the labeling.
• Ensure the proposed Prescribing Information (PI) conforms to the content and format regulations at 21 CFR 201.56(a) and (d) and 201.57.
• Submit carton and container labeling identical to the carton (wallet) labeling submitted August 18, 2020, and the container (blistercards) labeling submitted September 2, 2020.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to the deficiency.
• Describe in detail any significant changes or findings in the safety profile.

Cited reasons

• Failure to Submit Revised Labeling and Reach Agreement
• Prescribing Information (PI) Formatting and Content Deficiencies
• Carton and Container Labeling Inconsistencies
• Incomplete Safety Update
• The FDA issued a Complete Response Letter for Fexinidazole tablets, 600 mg, primarily due to the applicant's inability to submit revised labeling during the review cycle, preventing an agreement on product labeling. Additional deficiencies include non-conformance of Prescribing Information with formatting regulations and SPL requirements, inconsistencies in carton and container labeling, and an incomplete safety update lacking specific data elements and worldwide experience.

Recommended actions

• Submit draft labeling that addresses the FDA's proposed revisions communicated via email on November 4, 2020.
• 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, per 21 CFR 314.50(l)(1)(i).
• Provide a highlighted or marked-up copy showing all changes, with annotations, and a clean Word version of the labeling.
• Ensure the proposed Prescribing Information (PI) conforms to the content and format regulations at 21 CFR 201.56(a) and (d) and 201.57.
• Submit carton and container labeling identical to the carton (wallet) labeling submitted August 18, 2020, and the container (blistercards) labeling submitted September 2, 2020.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to the deficiency.
• Describe in detail any significant changes or findings in the safety profile.

Deficiency summary

The FDA issued a Complete Response Letter for Fexinidazole tablets, 600 mg, primarily due to the applicant's inability to submit revised labeling during the review cycle, preventing an agreement on product labeling. Additional deficiencies include non-conformance of Prescribing Information with formatting regulations and SPL requirements, inconsistencies in carton and container labeling, and an incomplete safety update lacking specific data elements and worldwide experience.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

NDA 505(b)

Impact

Impact score

0.75

Estimated delay

365 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The primary theme is the applicant's failure to finalize product labeling during the review cycle, compounded by several deficiencies in Prescribing Information content and format, carton/container labeling, and the completeness of the safety update, leading to a Complete Response.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%