Mylan Pharmaceuticals Inc.Abacavir and Lamivudine Tablets for Oral Suspension, 60 mg/30 mg

NDA 204311 COMPLETE RESPONSE

Mylan Pharmaceuticals Inc.

U.S. Agent for Mylan Laboratories Limited, India Attention: Shane Shupe, Director, Regulatory Affairs 781 Chestnut Ridge Road, P.O. Box 4310 Morgantown, WV 26504-4310

Dear Mr. Shupe:

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 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) During a recent inspection of the Mylan Laboratories Limited, Unit 8 (FEI # 3002785310) 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) Your proposed Prescribing Information (Pl) must conform to the content and

format regulations found at 21 CFR 201.56(a) and (d) and 201.57. As you develop your proposed PI, we encourage you to review the labeling review

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resources on the PLR Requirements for Prescribing Information’ and Pregnancy and Lactation Labeling Final Rule? websites, which include:

e The Final Rule (Physician Labeling Rule) on the content and format of the Pl for human drug and biological products

e The Final Rule (Pregnancy and Lactation Labeling Rule) on the content and format of information in the PI on pregnancy, lactation, and females and males of reproductive potential

e Regulations and related guidance documents

e Asample tool illustrating the format for Highlights and Contents, and

e The Selected Requirements for Prescribing Information (SRPI) - a checklist of important format items from labeling regulations and guidances.

e FDA's established pharmacologic class (EPC) text phrases for inclusion in the Highlights Indications and Usage heading.

Submit draft labeling based on our proposed revisions sent to you separately via email correspondence on August 6, 2019.

Prior to resubmitting the labeling, use the SRPI checklist to correct any formatting errors to ensure conformance with the 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.?

To facilitate review of your submission, provide a highlighted or marked-up copy that shows all changes, as well as a clean Microsoft Word version. The marked- up copy should include annotations that support any proposed changes.

CARTON AND CONTAINER LABELING

(3) Submit draft carton and container labeling based on our proposed revisions sent

to you separately via email on August 6, 2019.

’ http:/Awww.fda.gow/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm08415

9.htm

2 http://www. fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm09330

7.htm

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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MEDICATION GUIDE

(4) Submit draft labeling based on our proposed revisions sent to you separately via email on August 6, 2019.

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

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 may not be legally marketed until you have been notified in writing hat this application is approved.

If you have any questions, please call Monica Zeballos, Pharm.D., 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

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

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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 08/06/2019 03:12:06 PM

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