CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
`
`APPLICATION NUMBER:
`
` 204427Orig1s000
`
`
`
`
`
`Trade Name:
`
`Generic Name:
`
`
`Sponsor:
`
`
`
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`Approval Date:
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`Indications:
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` Kerydin topical solution, 5%
`
`Tavaborole
`
`Anacor Pharmaceuticals, Inc.
`
`July 7, 2013
`
`For the topical treatment of onychomycosis of the
`toenails due to Trichophyton rubrum or
`Trichophyton mentagrophytes.
`
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1071 - Page 1 of 9
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`

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`CENTER FOR DRUG EVALUATION AND RESEARCH
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`204427Orig1s000
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Medical Review(s)
`Chemistry Review(s)
`Environmental Assessment
`Pharmacology Review(s)
`Statistical Review(s)
`Microbiology / Virology Review(s)
`Clinical Pharmacology/Biopharmaceutics Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`
`X
`
`X
`
`X
`X
`X
`X
`X
`X
`
`X
`X
`X
`X
`X
`X
`X
`X
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`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1071 - Page 2 of 9
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`

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`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`204427Orig1s000
`APPROVAL LETTER
`
`
`
`
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`
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`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1071 - Page 3 of 9
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`
`Food and Drug Administration
`Silver Spring MD 20993
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`NDA APPROVAL
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`
`
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`NDA 204427
`
`
`Anacor Pharmaceuticals, Inc.
`Attention: Carmen Rodriguez, MSc
`Vice President, Regulatory Affairs and Quality
`1020 East Meadow Circle
`Palo Alto, CA 94309-4320
`
`
`
`Dear Ms. Rodriguez:
`
`Please refer to your New Drug Application (NDA) dated July 26, 2013, received July 29, 2013,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Kerydin (tavaborole) topical solution, 5%.
`
`We acknowledge receipt of your amendments dated August 9, 14 and 19, October 18, 23 and 30,
`November 18 and 25, and December 19 and 27, 2013: January 16, 21 and 31, April 1, 4 and 18,
`May 5, 13 and 20, and June 2, 11 and 23, 2014.
`
`This new drug application provides for the use of Kerydin (tavaborole) topical solution, 5% for
`the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or
`Trichophyton mentagrophytes.
`
`We have completed our review of this application, as amended. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
`patient package insert). Information on submitting SPL files using eLIST may be found in the
`guidance for industry SPL Standard for Content of Labeling Technical Qs and As, available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
`
`The SPL will be accessible via publicly available labeling repositories.
`
`
`Reference ID: 3537640
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1071 - Page 4 of 9
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`

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`NDA 204427
`Page 2
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`
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`CARTON AND IMMEDIATE CONTAINER LABELS
`
`Submit final printed carton and immediate container labels that are identical to the enclosed
`carton and immediate container labels, as soon as they are available, but no more than 30 days
`after they are printed. Please submit these labels electronically according to the guidance for
`industry Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical
`Product Applications and Related Submissions Using the eCTD Specifications (June 2008).
`Alternatively, you may submit 12 paper copies, with 6 of the copies individually mounted on
`heavy-weight paper or similar material. For administrative purposes, designate this submission
`“Final Printed Carton and Container Labels for approved NDA 204427.” Approval of this
`submission by FDA is not required before the labeling is used.
`
`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
`
`ADVISORY COMMITTEE
`
`Your application for (tavaborole) topical solution, 5% was not referred to an FDA advisory
`committee because outside expertise was not necessary; there were no controversial issues that
`would benefit from advisory committee discussion.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indications in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
`
`We are waiving the pediatric study requirement for ages 0 to 11 years and 11 months because
`necessary studies are impossible or highly impracticable. This is because onychomycosis due to
`Trichophyton rubrum or Trichophyton mentagrophytes is not prevalent in the population younger
`than 12 years of age.
`
`We are deferring submission of your pediatric study for ages 12 to 17 years and 11 months for
`this application because this product is ready for approval for use in adults and the pediatric
`study has not been completed.
`
`Your deferred pediatric study required by section 505B(a) of the FDCA is a required
`postmarketing study. The status of this postmarketing study must be reported annually according
`to 21 CFR 314.81 and section 505B(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. This
`required study is listed below.
`
`PMR 2154-1 Pharmacokinetic/safety study of tavaborole topical solution, 5% in 40 pediatric
`subjects age 12 to 17 years and 11 months with onychomycosis of the toenails.
`
`Reference ID: 3537640
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1071 - Page 5 of 9
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`

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`Pharmacokinetic assessments will be done in at least 16 evaluable subjects under
`maximal use conditions.
`
`Final Protocol Submission:
`Study Completion:
`
`Final Report Submission:
`
`
`
`
`
`12/2014
`12/2018
`06/2019
`
`NDA 204427
`Page 3
`
`
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`
`
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`Submit the protocol(s) to your IND 071206, with a cross-reference letter to this NDA.
`
`Reports of this required pediatric postmarketing study must be submitted as a new drug
`application (NDA) or as a supplement to your approved NDA with the proposed labeling
`changes you believe are warranted based on the data derived from these studies. When
`submitting the reports, please clearly mark your submission "SUBMISSION OF REQUIRED
`PEDIATRIC ASSESSMENTS" in large font, bolded type at the beginning of the cover letter of
`the submission.
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert
`to:
`
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
`2253. Form FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`
`
`Reference ID: 3537640
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1071 - Page 6 of 9
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`

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`NDA 204427
`Page 4
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`
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`MEDWATCH-TO-MANUFACTURER PROGRAM
`
`The MedWatch-to-Manufacturer Program provides manufacturers with copies of serious adverse
`event reports that are received directly by the FDA. New molecular entities and important new
`biologics qualify for inclusion for three years after approval. Your firm is eligible to receive
`copies of reports for this product. To participate in the program, please see the enrollment
`instructions and program description details at
`http://www.fda.gov/Safety/MedWatch/HowToReport/ucm166910.htm.
`
`POST APPROVAL FEEDBACK MEETING
`
`New molecular entities and new biologics qualify for a post approval feedback meeting. Such
`meetings are used to discuss the quality of the application and to evaluate the communication
`process during drug development and marketing application review. The purpose is to learn
`from successful aspects of the review process and to identify areas that could benefit from
`improvement. If you would like to have such a meeting with us, call the Regulatory Project
`Manager for this application.
`
`PDUFA V APPLICANT INTERVIEW
`
`FDA has contracted with Eastern Research Group, Inc. (ERG) to conduct an independent interim
`and final assessment of the Program for Enhanced Review Transparency and Communication for
`NME NDAs and Original BLAs under PDUFA V (‘the Program’). The PDUFA V Commitment
`Letter states that these assessments will include interviews with applicants following FDA action
`on applications reviewed in the Program. For this purpose, first-cycle actions include approvals,
`complete responses, and withdrawals after filing. The purpose of the interview is to better
`understand applicant experiences with the Program and its ability to improve transparency and
`communication during FDA review.
`
`ERG will contact you to schedule a PDUFA V applicant interview and provide specifics about
`the interview process. Your responses during the interview will be confidential with respect to
`the FDA review team. ERG has signed a non-disclosure agreement and will not disclose any
`identifying information to anyone outside their project team. They will report only anonymized
`results and findings in the interim and final assessments. Members of the FDA review team will
`be interviewed by ERG separately. While your participation in the interview is voluntary, your
`feedback will be helpful to these assessments.
`
`
`Reference ID: 3537640
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1071 - Page 7 of 9
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`

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`NDA 204427
`Page 5
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`
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`If you have any questions, call Cristina Attinello, Senior Regulatory Project Manager, at (301)
`796-3986.
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Amy G. Egan, MD, MPH
`Deputy Director (acting)
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`
`Enclosures:
`Content of Labeling
`Carton and Container Labeling
`
`Reference ID: 3537640
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1071 - Page 8 of 9
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`

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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`AMY G EGAN
`07/07/2014
`
`Reference ID: 3537640
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1071 - Page 9 of 9