CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
`
`
`
`APPLICATION NUMBER:
`
`203567Orig1s000
`
`Jublia topical solution, 10%
`
`Trade Name:
`
`efinaconazole
`Generic Name:
`
`Sponsor:
`
`Approval Date:
`
`Indications:
`
`Dow Pharmaceutical Sciences, Inc.
`
`June 6, 2014
`
` For the topical treatment of onychomycosis of the
`toenails due to Trichophyton rubrum and
`Trichophyton mentagrophytes.
`
`(
`
`
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1069 - Page 1 of 8
`
`

`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`203567Orig1s000
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`X
`X
`X
`
`X
`X
`X
`
`X
`X
`
`X
`X
`X
`X
`X
`X
`X
`X
`
`
`
`
`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)
`
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1069 - Page 2 of 8
`
`

`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`203567Orig1s000
`APPROVAL LETTER
`
`
`
`
`
`
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1069 - Page 3 of 8
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`

`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`NDA APPROVAL
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`NDA 203567
`
`
`Dow Pharmaceutical Sciences, Inc.
`Attention: Sean Humphrey
`Manager, Regulatory Affairs
`1330 Redwood Way
`Petaluma, CA 94954
`
`
`
`Dear Mr. Humphrey:
`
`Please refer to your New Drug Application (NDA) dated and received on July 25, 2012,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Jublia
`(efinaconazole) topical solution, 10%.
`
`We acknowledge receipt of your amendments dated August 6, 10, and 20, September 26,
`October 17 and 22, December 6, 7, 14, 19 and 20, 2012; January 9 and 17, March 18 and
`29, December 20, 2013; January 16, February 4, May 16, 23 and 27, June 4, 2014.
`
`The December 20, 2013, submission constituted a complete response to our May 13, 2013,
`action letter.
`
`This new drug application provides for the use of Jublia (efinaconazole) topical solution, 10%
`for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and
`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, and text for the instructions for use). 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
`
`Reference ID: 3519795
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1069 - Page 4 of 8
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`

`
`NDA 203567
`Page 2
`
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
`The SPL will be accessible via publicly available labeling repositories.
`
`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 203567.” 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 Jublia (efinaconazole) topical solution, 10% was not referred to an FDA
`advisory committee because the application did not raise significant public health questions on
`the role of the drug in the diagnosis, cure, mitigation, treatment, or prevention of a disease.
`
`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 indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
`
`We are waiving the pediatric study requirement for ages 0 years to 11 years, 11 months because
`necessary studies are impossible or highly impracticable. There appears to be few culture
`positive cases of onychomycosis in subjects less than 12 years of age in the general population.
`
`We are deferring submission of your pediatric study for ages 12 to less than 17 years 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 FDCA. This required study is listed below.
`
`
`2156-1 A multicenter, randomized, double-blind study evaluating the safety, efficacy and
`pharmacokinetics of Jublia (efinaconazole) topical solution, 10% versus vehicle in
`
`Reference ID: 3519795
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1069 - Page 5 of 8
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`

`
`NDA 203567
`Page 3
`
`
`
`
`pediatric subjects ages 12 to less than 17 years with onychomycosis of the
`toenails
`
`Final Protocol Submission: 09/14
`Study Completion:
`
` 03/18
`Final Report Submission:
` 09/18
`
`
`Submit the protocol to your IND 077732, 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: 3519795
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1069 - Page 6 of 8
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`

`
`NDA 203567
`Page 4
`
`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.
`
`If you have any questions, call Strother D. Dixon, Regulatory Project Manager, at (301) 795-
`1015.
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Julie Beitz, MD
`Director
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
`
`
`
`
`
`Enclosures:
`Content of Labeling
`Carton and Container Labeling
`
`Reference ID: 3519795
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1069 - Page 7 of 8
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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/
`----------------------------------------------------
`
`JULIE G BEITZ
`06/06/2014
`
`Reference ID: 3519795
`
`CFAD v. Anacor, IPR2015-01776, CFAD EXHIBIT 1069 - Page 8 of 8