Mylan Pharmaceuticals Inc., a Viatris CompanyAbacavir and Lamivudine Tablets for Oral Suspension, 60 mg/30 mg

NDA 204311 COMPLETE RESPONSE

Mylan Pharmaceuticals Inc., a Viatris Company

U.S. Agent for Mylan Laboratories Limited, a Viatris Company, India Attention: Beth Britton

Senior Director, Regulatory Affairs

3711 Collins Ferry Road

Morgantown, WV 26505

Dear Ms. Britton:

Please refer to your new drug application (NDA) dated and received December 23, 2013, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for the following drug product:

> Abacavir and Lamivudine Tablets for Oral Suspension, 60 mg/30 mg

We acknowledge receipt of your amendment dated February 6, 2019, which constituted a complete response to our October 23, 2014, tentative approval letter. We also acknowledge receipt of your amendment dated July 15, 2022, which constituted a complete response to our August 6, 2019, complete response letter.

We have completed our review of this application, as amended, and have determined that we cannot 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) Following surveillance inspection of Mylan Laboratories Limited Unit-8, a Viatris Company (FEI # 30002785310, Vizianagaram, Andhra Pradesh, India) manufacturing facility listed in this application, FDA conveyed deficiencies to the representatives of the facility. 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

Reference ID: 5109697

NDA 204311 Page 2

CARTON AND CONTAINER LABELING

Prescription Drug Labeling Resources! 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.

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(I)(1)(i)] in structured product labeling (SPL) format as described at FDA.gov.?

(3) We reserve comment on the proposed labeling until the application is otherwise

ADDITIONAL COMMENTS

adequate.

We have the following comment and recommendation that are not approvability issues:

(4) Based on our regulatory and scientific review of your application, we have

preliminarily determined that there is no need to rely for approval on FDA’ s finding of safety and/or effectiveness for a

because FDA’s finding of safety and/or effectiveness for the other two relied-upon listed drugs, Ziagen (abacavir sulfate) oral solution, NDA 020978, and Epivir (lamivudine) oral solution, NDA 020596, appear adequate to support approval of your 505(b)(2) application. Therefore, in your future submissions to this application, including any resubmission, please update your Form FDA 356h (Field 20), cover letter, and annotated labeling to omit identification of ™® as a basis for approval of your application.

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.

https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources

2 https://www.fda.gov/drugs/labeling-information-drug-products/pregnancy-and-lactation-labeling-drugs-

final-rule 3 http://www.fda.gov/Forlndustry/DataStandards/StructuredProductLabeling/default.htm

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov

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NDA 204311 Page 3

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

his 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 ‘ake before the application may be approved. If you wish to have such a meeting, submit your meeting request as described in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.

The drug product is not eligible for procurement under the President's Emergency Plan or AIDS Relief (PEPFAR) program unless and until you have been notified in writing hat, based on your resubmission, the application is tentatively approved.

If you have any questions, call Monica Zeballos, Sr. Program Consultant, at (301) 796- 0840.

Sincerely yours, {See appended electronic signature page}

Sarita Boyd, Pharm.D.

Associate Director for PEPFAR

Division of Antivirals

Office of Infectious Diseases

Office of New Drugs

Center for Drug Evaluation and Research

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov

Reference ID: 5109697

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.

SARITA D BOYD 01/13/2023 03:17:43 PM

Reference ID: 5109697