Approval Letter Other 210649 (Jan 1, 2019)

Summary

This document is a Complete Response letter from the FDA to AB Pharmaceuticals, LLC, regarding New Drug Application (NDA) 210649 for Efavirenz, Lamivudine, and Tenofovir Disoproxil Fumarate Tablets. The FDA has determined that the application cannot be tentatively approved in its present form due to deficiencies related to facility inspections and prescribing information.

Key points

• Satisfactory resolution of objectionable conditions observed during the inspection of the Macleods Pharmaceuticals Limited manufacturing facility is required before the NDA may be approved.
• If labeling is revised, the applicant must use the SRPI checklist to ensure the prescribing information conforms with format items in regulations and guidances.
• Any revised labeling response must include updated content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format.
• Within one year after the date of the letter, the applicant is required to resubmit the application or take other actions available under 21 CFR 314.110.
• A resubmission must fully address all deficiencies listed in the letter and be clearly marked with 'RESUBMISSION' in large, bolded type at the beginning of the cover letter.
• The cover letter for a resubmission must clearly state that it is considered a complete response to the outlined deficiencies.
• During a recent inspection of the Macleods Pharmaceuticals Limited manufacturing facility, our field investigator observed objectionable conditions. Satisfactory resolution of these observations is required before this NDA may be approved.
• The agency reserves comment on the proposed labeling until the application is otherwise adequate. However, the response must include updated content of labeling in structured product labeling (SPL) format. The applicant is encouraged to review PLR Requirements, Pregnancy and Lactation Labeling Final Rule websites, and the SRPI checklist.

Cited reasons

• Unsatisfactory Manufacturing Facility Inspection Findings
• Inadequate Prescribing Information Format and Content
• The application received a Complete Response due to objectionable conditions observed during a manufacturing facility inspection and inadequate prescribing information requiring updates to content and SPL format.

Recommended actions

• Satisfactory resolution of objectionable conditions observed during the inspection of the Macleods Pharmaceuticals Limited manufacturing facility is required before the NDA may be approved.
• If labeling is revised, the applicant must use the SRPI checklist to ensure the prescribing information conforms with format items in regulations and guidances.
• Any revised labeling response must include updated content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format.
• Within one year after the date of the letter, the applicant is required to resubmit the application or take other actions available under 21 CFR 314.110.
• A resubmission must fully address all deficiencies listed in the letter and be clearly marked with 'RESUBMISSION' in large, bolded type at the beginning of the cover letter.
• The cover letter for a resubmission must clearly state that it is considered a complete response to the outlined deficiencies.

Deficiency summary

The application received a Complete Response due to objectionable conditions observed during a manufacturing facility inspection and inadequate prescribing information requiring updates to content and SPL format.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

NDA 505(b)(2)

Impact

Impact score

0.95

Estimated delay

365 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The application received a Complete Response due to objectionable conditions observed during a manufacturing facility inspection and inadequate prescribing information requiring updates to content and SPL format.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%