AB Pharmaceuticals, LLCEfavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg

NDA 210649 COMPLETE RESPONSE

AB Pharmaceuticals, LLC

U.S. Agent for Macleods Pharmaceuticals Limited, India Attention: Andrej Gasperlin, President

17471 Highland Way Drive

Chesterfield, MO 63005

Dear Mr. Gasperlin:

Please refer to your New Drug Application (NDA) dated and received September 14, 2017, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for the following drug product:

> Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg

We acknowledge receipt of your amendment dated March 15, 2018, which constituted a complete response to our March 13, 2018, action letter.

We have completed our review of this application, as amended, and have determined that we cannot tentatively approve this application in its present form. We have described our reasons for this action below and, where possible, our recommendations to address these issues.

FACILITY INSPECTIONS

1. During a recent inspection of the Macleods Pharmaceuticals Limited (FEI # 3007517881) manufacturing facility for this NDA, our field investigator observed objectionable conditions at the facility and conveyed that information to the representative of the facility at the close of the inspection. Satisfactory resolution of the observations is required before this NDA may be approved.

PRESCRIBING INFORMATION

2. We reserve comment on the proposed labeling until the application is otherwise adequate. We encourage you to review the labeling review resources on the PLR Requirements for Prescribing Information and Pregnancy and Lactation Labeling Final Rule websites, including regulations and related guidance documents and the Selected Requirements for Prescribing Information (SRPI) — a checklist of important format items from labeling regulations and guidances.

Reference ID: 4319870

NDA 210649 Page 2

If you revise labeling, use the SRPI checklist to ensure that the prescribing information conforms with format items in regulations and guidances. Your response must include updated content of labeling [21 CFR 314.50(1)(1)()] in structured product labeling (SPL) format as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm

OTHER

Within one year after the date of this letter, you are required to resubmit or take other actions available under 21 CFR 314.110. If you do not take one of these actions, we may consider your lack of response a request to withdraw the application under 21 CFR 314.65. You may also request an extension of time in which to resubmit the application.

A resubmission must fully address all the deficiencies listed in this letter and should be clearly marked with "RESUBMISSION" in large font, bolded type at the beginning of the cover letter of the submission. The cover letter should clearly state that you consider this resubmission a complete response to the deficiencies outlined in this letter. A partial response to this letter will not be processed as a resubmission and will not start a new review cycle.

You may request a meeting or teleconference with us to discuss what steps you need to take efore the application may be approved. If you wish to have such a meeting, submit your meeting request as described in the draft FDA Guidance for Industry, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,” December 2017 at ttps://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM59054 1.

The drug product is not eligible for procurement under the President’s Emergency Plan for AIDS Relief (PEPFAR) program until you have been notified in writing that this application is approved.

f you have any questions, please call Monica Zeballos, Program Coordinator, at (301) 796-0840.

Sincerely yours, {See appended electronic signature page}

Jeffrey Murray, M.D., M.P.H.

Deputy Director

Division of Antiviral Products

Office of Antimicrobial Products

Center for Drug Evaluation and Research

Reference ID: 4319870

Signature Page 1 of 1

This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.

JEFFREY S MURRAY 09/12/2018

Reference ID: 4319870