CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`203567Orig1s000
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`

`

`EXCLUSIVITY SUMMARY
`
`SUPPL # NA
`
`HFD # NA
`
`NDA # 203567
`
`Trade Name Jublia
`
`Generic Name (efinaconazole) topical solution, 10%
`
`Applicant Name Dow Pharmaceutical Sciences
`
`
`
`Approval Date, If Known June 20, 2014
`
`PART I
`
`IS AN EXCLUSIVITY DETERMINATION NEEDED?
`
`1. An exclusivity determination will be made for all original applications, and all efficacy
`supplements. Complete PARTS II and III of this Exclusivity Summary only if you answer "yes" to
`one or more of the following questions about the submission.
`
`a) Is it a 505(b)(1), 505(b)(2) or efficacy supplement?
`
` YES
`
`NO
`
`If yes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
`
`505(b)(1)
`
`c) Did it require the review of clinical data other than to support a safety claim or change in
`labeling related to safety? (If it required review only of bioavailability or bioequivalence
`data, answer "no.")
`
` YES
`
`NO
`
`If your answer is "no" because you believe the study is a bioavailability study and, therefore,
`not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your
`reasons for disagreeing with any arguments made by the applicant that the study was not
`simply a bioavailability study.
`
`If it is a supplement requiring the review of clinical data but it is not an effectiveness
`supplement, describe the change or claim that is supported by the clinical data:
`
`
`
`Reference ID: 3509284
`
`Page 1
`
`

`

`d) Did the applicant request exclusivity?
`
`YES
`
`NO
`
`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
`
`5
`
`e) Has pediatric exclusivity been granted for this Active Moiety?
`YES
`
`NO
`
` If the answer to the above question in YES, is this approval a result of the studies submitted in
`response to the Pediatric Written Request?
`
`
`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY TO
`THE SIGNATURE BLOCKS AT THE END OF THIS DOCUMENT.
`
`2. Is this drug product or indication a DESI upgrade?
`
`YES
`
`NO
`
`IF THE ANSWER TO QUESTION 2 IS "YES," GO DIRECTLY TO THE SIGNATURE BLOCKS
`ON PAGE 8 (even if a study was required for the upgrade).
`
`FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES
`PART II
`(Answer either #1 or #2 as appropriate)
`
`1. Single active ingredient product.
`
`Has FDA previously approved under section 505 of the Act any drug product containing the same
`active moiety as the drug under consideration? Answer "yes" if the active moiety (including other
`esterified forms, salts, complexes, chelates or clathrates) has been previously approved, but this
`particular form of the active moiety, e.g., this particular ester or salt (including salts with hydrogen or
`coordination bonding) or other non-covalent derivative (such as a complex, chelate, or clathrate) has
`not been approved. Answer "no" if the compound requires metabolic conversion (other than
`deesterification of an esterified form of the drug) to produce an already approved active moiety.
`
`
`
`
`
`YES
`
`NO
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`
`
`
`Reference ID: 3509284
`
`Page 2
`
`

`

`NDA#
`
`NDA#
`
`NDA#
`
`2. Combination product.
`
`If the product contains more than one active moiety(as defined in Part II, #1), has FDA previously
`approved an application under section 505 containing any one of the active moieties in the drug
`product? If, for example, the combination contains one never-before-approved active moiety and
`one previously approved active moiety, answer "yes." (An active moiety that is marketed under an
`OTC monograph, but that was never approved under an NDA, is considered not previously
`approved.)
`
`YES
`
`NO
`
`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
`
`NDA#
`NDA#
`NDA#
`
`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART II IS "NO," GO DIRECTLY TO THE
`SIGNATURE BLOCKS ON PAGE 8. (Caution: The questions in part II of the summary should
`only be answered “NO” for original approvals of new molecular entities.)
`IF “YES,” GO TO PART III.
`
`PART III
`
`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
`
`To qualify for three years of exclusivity, an application or supplement must contain "reports of new
`clinical investigations (other than bioavailability studies) essential to the approval of the application
`and conducted or sponsored by the applicant." This section should be completed only if the answer
`to PART II, Question 1 or 2 was "yes."
`
`1. Does the application contain reports of clinical investigations? (The Agency interprets "clinical
`investigations" to mean investigations conducted on humans other than bioavailability studies.) If
`the application contains clinical investigations only by virtue of a right of reference to clinical
`investigations in another application, answer "yes," then skip to question 3(a). If the answer to 3(a)
`
`Reference ID: 3509284
`
`Page 3
`
`

`

`is "yes" for any investigation referred to in another application, do not complete remainder of
`summary for that investigation.
`
`YES
`
`NO
`
`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
`
`2. A clinical investigation is "essential to the approval" if the Agency could not have approved the
`application or supplement without relying on that investigation. Thus, the investigation is not
`essential to the approval if 1) no clinical investigation is necessary to support the supplement or
`application in light of previously approved applications (i.e., information other than clinical trials,
`such as bioavailability data, would be sufficient to provide a basis for approval as an ANDA or
`505(b)(2) application because of what is already known about a previously approved product), or 2)
`there are published reports of studies (other than those conducted or sponsored by the applicant) or
`other publicly available data that independently would have been sufficient to support approval of
`the application, without reference to the clinical investigation submitted in the application.
`
`(a) In light of previously approved applications, is a clinical investigation (either conducted
`by the applicant or available from some other source, including the published literature)
`necessary to support approval of the application or supplement?
`YES
`
`NO
`
`If "no," state the basis for your conclusion that a clinical trial is not necessary for approval
`AND GO DIRECTLY TO SIGNATURE BLOCK ON PAGE 8:
`
`
`(b) Did the applicant submit a list of published studies relevant to the safety and effectiveness
`of this drug product and a statement that the publicly available data would not independently
`support approval of the application?
`
`YES
`
`NO
`
`(1) If the answer to 2(b) is "yes," do you personally know of any reason to disagree
`with the applicant's conclusion? If not applicable, answer NO.
`
`YES
`
`NO
`
` If yes, explain:
`
`
`
`
`
`(2) If the answer to 2(b) is "no," are you aware of published studies not conducted or
`sponsored by the applicant or other publicly available data that could independently
`demonstrate the safety and effectiveness of this drug product?
`
`Reference ID: 3509284
`
`Page 4
`
`

`

`YES
`
`NO
`
` If yes, explain:
`
`
`
`(c)
`
`If the answers to (b)(1) and (b)(2) were both "no," identify the clinical investigations
`submitted in the application that are essential to the approval:
`
`DPSI-IDP-108-P3-01 and -02: Phase 3 Clinical Trials
`DPSI-IDP-108-P3-02 and -02: Phase 3 Clinical Trials
`
`
`Studies comparing two products with the same ingredient(s) are considered to be bioavailability
`studies for the purpose of this section.
`
`3. In addition to being essential, investigations must be "new" to support exclusivity. The agency
`interprets "new clinical investigation" to mean an investigation that 1) has not been relied on by the
`agency to demonstrate the effectiveness of a previously approved drug for any indication and 2) does
`not duplicate the results of another investigation that was relied on by the agency to demonstrate the
`effectiveness of a previously approved drug product, i.e., does not redemonstrate something the
`agency considers to have been demonstrated in an already approved application.
`
`a) For each investigation identified as "essential to the approval," has the investigation been
`relied on by the agency to demonstrate the effectiveness of a previously approved drug
`product? (If the investigation was relied on only to support the safety of a previously
`approved drug, answer "no.")
`
`Investigation #1
`
`Investigation #2
`
`
`
`YES
`
`YES
`
`
`
`NO
`
`NO
`
`If you have answered "yes" for one or more investigations, identify each such investigation
`and the NDA in which each was relied upon:
`
`b) For each investigation identified as "essential to the approval", does the investigation
`duplicate the results of another investigation that was relied on by the agency to support the
`effectiveness of a previously approved drug product?
`
`Investigation #1
`
`Investigation #2
`
`YES
`
`YES
`
`NO
`
`NO
`
`Reference ID: 3509284
`
`Page 5
`
`

`

`If you have answered "yes" for one or more investigation, identify the NDA in which a
`similar investigation was relied on:
`
`c) If the answers to 3(a) and 3(b) are no, identify each "new" investigation in the application
`or supplement that is essential to the approval (i.e., the investigations listed in #2(c), less any
`that are not "new"):
`
`DPSI-IDP-108-P3-01 and -02: Phase 3 Clinical Trials
`DPSI-IDP-108-P3-02 and -02: Phase 3 Clinical Trials
`
`4. To be eligible for exclusivity, a new investigation that is essential to approval must also have
`been conducted or sponsored by the applicant. An investigation was "conducted or sponsored by"
`the applicant if, before or during the conduct of the investigation, 1) the applicant was the sponsor of
`the IND named in the form FDA 1571 filed with the Agency, or 2) the applicant (or its predecessor
`in interest) provided substantial support for the study. Ordinarily, substantial support will mean
`providing 50 percent or more of the cost of the study.
`
`a) For each investigation identified in response to question 3(c): if the investigation was
`carried out under an IND, was the applicant identified on the FDA 1571 as the sponsor?
`
`
`
`!!
`
`! NO
`! Explain:
`
`
`
`!!
`
`
`! NO
`! Explain:
`
`Investigation #1
`
`IND #
`
`YES
`
`
`
`Investigation #2
`
`IND #
`
`YES
`
`
`
`
`
`
`(b) For each investigation not carried out under an IND or for which the applicant was not
`identified as the sponsor, did the applicant certify that it or the applicant's predecessor in
`interest provided substantial support for the study?
`
`Reference ID: 3509284
`
`Page 6
`
`

`

`!!
`
`
`! NO
`! Explain:
`
`!!
`
`
`! NO
`! Explain:
`
`Investigation #1
`
`YES
`Explain:
`
`
`
`Investigation #2
`
`YES
`Explain:
`
`
`
`
`
`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe that
`the applicant should not be credited with having "conducted or sponsored" the study?
`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to the
`drug are purchased (not just studies on the drug), the applicant may be considered to have
`sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)
`
`YES
`
`NO
`
`If yes, explain:
`
`=================================================================
`
`Name of person completing form: Strother D. Dixon
`Title: Regulatory Project Manager
`Date: May 16, 2014
`
`
`Name of Office/Division Director signing form: Stanka Kukich, M.D.
`Title: Deputy Director, Division of Dermatology and Dental Products
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05; removed hidden data 8/22/12;
`
`Reference ID: 3509284
`
`Page 7
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`STROTHER D DIXON
`05/19/2014
`
`DAVID L KETTL
`05/19/2014
`
`STANKA KUKICH
`05/22/2014
`
`Reference ID: 3509284
`
`

`

`1.3.3 Debarment Certification
`
`Debarment Certification
`
`Dow Pharmaceutical Sciences herewith certifies that the services of any persons debarred under
`Section 306(a) or (b) were not and will not be used in any capacity in conjunction with this
`application.
`
`aM”--_
`
`
`
`Tage Ramakrishna, MD
`Chief Medical Officer
`
`

`

`ACTION PACKAGE CHECKLIST
`
`NDA # 203567
`BLA # NA
`
`NDA Supplement # NA
`BLA Supplement # NA
`
`IfNDA. Eflicacy Supplement Type: NA
`(an action package is not requiredfor SE8 or SE9 supplements)
`
`Jublia
`Proprietary Name:
`Established/Proper Name: (efinaconazole)
`Dosage Form:
`topical solution
`
`Applicant: Dow Pharmaceutical Sciences
`Agent for Applicant (if applicable): NA
`
`RPM: Strother D. Dixon
`
`Division: Dermatology and Dental Products
`
`[:I 505(b)(2)
`IX] 505(b)(1)
`NDA Application Type:
`Efficacy Supplement: D 505(b)(1) D 505(b)(2)
`'
`.
`BLA APPl‘camn Type: E] 3510‘) D 3510‘)
`Efficacy supplement: D 3510‘) E] 351(3)
`
`. Review the information in the 505(b)(2) Assessment and submit
`the draft‘ to CDER 0ND 10 for clearance.
`Check Orange Book for newly listed patents and/or
`exclusivity (including pediatric exclusivity)
`
`For ALL 50519112} application; two months prior to EVERY action:
`
`|:] No changes
`|:] New patent/exclusivity (notifv CDER 0ND 10)
`Date of check:
`
`Note: Ifpediatric exclusivity has been granted or the pediatric
`information in the labeling ofthe listed drug changed, determine whether
`pediatric information needs to be added to or deletedfrom the labeling of
`this drug.
`
`
`
`UserFee Goal Date15 June 20. 2014
`Previous actions (spectfi type and datefor each action taken)
`Ifaccelerated approval or approval based on efficacy studiesin animals. were promotional
`materials received?
`
`Note: Promotional materials to be used within 120 days afier approval must have been
`submitted (for exceptions. see
`llgpzflwww fda.gov/downloads/Drugs/GuidanceComplianceRegylatogInfonnation/Guida
`11ces/uc111069965pdfi). Ifnot submitted. explain
`
`DCR
`El TA
`IX] AP
`I: None CR — May 13. 2013
`
`Application Characteristics 3
`
`l The Application Information Section is (only) a checklist. The Contents ofAction Package Section (beginning on page 2) lists
`the documents to be included in the Action Package.
`2 For resubmissions. 505(b)(2) applications must be cleared before the action. but it is not necessary to resubmit the draft 505(b)(2)
`Assessment to CDER 0ND IO unless the Assessment has been substantively revised (e.g... new listed drug, patent certification
`revised).
`3 Answer all questions in all sections in relation to the pending application. i.e., if the pending application is an NDA or BLA
`supplement. then the questions should be answered in relation to that supplement. not in relation to the original NDA or BLA. For
`example, if the application is a pending BLA supplement, then a new RMS—BLA Product Information Sheetfor TBP must be
`completed.
`
`Version: 5/14/2014
`
`Reference ID: 3520929
`
`

`

`NDA/BLA #
`
`Page 2
`
`I:I Priority
`IX] Standard
`Review priority:
`Chemical classification (new NDAs only):
`(confirm chemical classification at time ofapproval)
`
`|:| Fast Track
`[I Rolling Review
`[I Orphan drug designation
`[I Breakthrough Therapy designation
`
`[J Rx-to-OTC full switch
`[:I Rx-to—OTC partial switch
`E] Direct-to-OTC
`
`NDAs: Subpart H
`D Accelerated approval (21 CFR 314.510)
`I:] Restricted distribution (21 CFR 314.520)
`Subpart I
`[3 Approval based on animal studies
`
`BLAs: Subpart E
`D Accelerated approval (21 CFR 601.41)
`I:] Restricted distribution (21 CFR 601.42)
`Subpart H
`D Approval based on animal studies
`
`I:I Submitted in response to a PMR
`I:I Submitted in response to a PMC
`D Submitted in response to a Pediatric Written Request
`
`Comments:
`
`REMS: I:] MedGuide
`I:] Communication Plan
`I:] ETASU
`D MedGuide w/o REMS
`1:] REMS not required
`
`0
`0.. BLAs only: Ensure RMS—BLA Product Information Sheetfor IBP and RMS—BLA Facilily
`Information Sheetfor TBP have been completed and forwarded to OPI/OBI/DRM (Vicky
`Carter
`
`I: Yes. dates
`
`°2° BLAs only: Is the product subject to official FDA lot release per 21 CFR 610.2
`(approvals only)
`
`I: Yes
`
`[3 No
`
`'20 Public communications (approvals only)
`
`0 Office of Executive Programs (OEP) liaison has been notified of action
`
`0
`
`Indicate what types (ifany) ofinformation were issued
`
`IE Yes D No
`I: None
`|:] FDA Press Release
`
`E 21211:}:3:22pm
`
`IX Other Approval Page &
`weekly FDA News & Notes
`
`°2° Exclusivity
`
`0
`
`0
`
`Is approval of this application blocked by any type of exclusivity (orphan. 5-year
`NCE. 3-year. pediatric exclusivity)?
`Ifso. so-c'
`the p-
`
`IE No
`
`[:I Yes
`
`°3° Patent Information (NDAs only)
`
`0
`
`Patent Information:
`
`Verify that form FDA-3 542a was submitted for patents that claim the drug for
`which approval is sought.
`
`g Verified
`I:] Not applicable because drug is
`an old antibiotic.
`
`
`
`
`
`Reference ID: 3520929
`
`Versiom 5/14/2014
`
`

`

`NDA/BLA #
`
`Page 3
`
`
`
`List of oflicers/employees who participated in the decision to approve this application and
`consented to be identified on this list (approvals only)
`
`E Included 6/2/14
`
`Documentation of consent/non-consent by officers/employees
`
`X] Included 6/2/14
`
`
`
`
`
`
`
`
`Action(s) and date(s) Approval
`.0
`Copies of all action letters (including approval letter withfinal labeling)
`6/6/14; CR May 13, 2013 (no
`
`labeling)
`
`
`
`
`Package Insert (write submission/communication date at upper light offirst page ofPI)
` X] Included 6/4/14
`
`Most recent drafi labeling (iit is division-proposed labeling, it should be in
`hack-changesformat)
`
`Original applicant—proposed labeling
`
`Medication Guide/Patient Package Insert/Instructions for Use/Device labeling (write
`submission/communication date at upper right offirstpage ofeach piece)
`
`Most-recent draft labeling (Ifit is division—proposed labeling, it should be in
`h‘aclr-changesformat)
`
`Original applicant-proposed labeling
`
`Labels (full color carton and immediate-container labels) (write
`submission/communication date on upper right offirstpage ofeach submission)
`
`0 Most-recent draft labeling
`
`Proprietary Name
`0 Acceptability/non-acceptability letter(s) (indicate date(s))
`0
`Review(s) (indicate date(s)
`
`labeling reviews (indicate dates ofreviews)
`
`12/20/l 3 (resub)
`6/26/12 (original)
`
`
`I:] Medication Guide
`IX Patient Package Insert
`IX Instructions for Use
`E] Device Labeling
`D None
`
`g Included May 23, 2014
`
`December 20, 2013 (resub)
`June 26, 2012 (original)
`
`X] Included May 16, 2014
`
`3/29/14 — Acceptable Letter
`3-26-14 - Acceptable Review
`4/15/ 13 - Acceptable Letter
`4/12/13 - Acceptable Review
`11/9/ 12 - Not Acceptable Letter
`11/9/12 - Not Acc table Review
`
`RPM: 1] None 4/30/14; 9/25/12
`DMEPA: I] None 3/14/14,
`2/28/13
`
`DMPP/PLT (DRISK):
`E] None 3/31/14,
`3/5/2013 (deferral memo)
`OPDP: I:I None 3/28/14, 8/2/13
`SEALD: [Z None
`CSS: IX] None
`Other: IE None
`
`
`
`
`Version: 5/14/2014
`
`O0
`
`O0
`
`.0
`
`O0
`
`.0
`
`O0
`
`.0
`
`O0
`
`.0
`
`O0
`
`.0
`
`
`
`Reference ID: 3520929
`
`

`

`
`
`NDA/BLA #
`
`Page 4
`
`RPM Filing Review‘lMemo of Filing Meeting (indicate date ofeach review)
`All NDA 505(b)(2) Actions: Date each action cleared by 505(b)(2) Clearance Committee
`
`10/1/12
`
`IX Not 3 (19(2)
`
`NDAs only: Exclusivity Summary (signed by Division Director)
`
`E Included 5/22/14
`
`Application Integrity Policy (AIP) Status and Related Documents
`http://www fda.govflCECI/EnforcementActions/ApylicationInteggjflPolicy/defaulthtm
`
`Applicant is on the AIP
`
`This application is on the AIP
`
`C O
`
`o
`
`0
`
`Ifyes, Center Director’s Exception for Review memo (indicate date)
`
`Ifyes. 0C clearance for approval (indicate date ofclearance
`communication)
`
`I:I Not an AP action
`
`Pediatrics (approvals only)
`O
`Date reviewed by PeRC 4/30/14
`If PeRC review not necessary. explain:
`
`Outgoing commlmications: letters. emails. and faxes considered important to include in
`the action package by the reviewing office/division (e.g.. clinical SPA letters. RTF letter.
`etc.) (do not include previous action letters, as these are located elsewhere in package)
`
`1/30/14 Information Request
`12/30/ 13 Acknowledgement
`9/4/13 Verbal Advice
`
`3/8/13 Discipline Review
`12/2 1/ 12 Information Request
`1 1/20/ 12 Informaiton Request
`10/1 7/ 1 2 MV Materials Received
`
`9/28/12 MV Materials Requested
`9/27/12 Filing w/ Issues
`8/10/12 Email IR
`8/2/ 12 IR
`
`7/27/12 Acknowledgement
`
`Internal documents: memoranda, telecons. emails. and other documents considered
`important to include in the action package by the reviewing oflice/division (e.g..
`Regulatory Briefing minutes. Medical Policy Council meeting minutes)
`
`11/15/12
`
`O0
`
`O0
`
`..
`..
`
`O
`0.0
`
`O0
`
`..
`
`O0
`
`..
`
`O0
`
`..
`
`O0
`
`..
`
`°2° Minutes of Meetings
`
`Ifnot the first review cycle. any end-of-review meeting (indicate date ofmtg)
`
`E] N/Aornomtg 7/17/13
`
`Pre—NDA/BLA meeting (indicate date ofmtg)
`
`lj Nomtg 4/17/12
`
`EOP2 meeting (indicate date ofmtg)
`
`Mid-cycle Communication (indicate date ofmtg)
`
`Late-cycle Meeting (indicate date ofmtg)
`
`Other milestone meetings (e.g.. EOP2a. CMC pilots) (indicate dates ofmtgs)
`
`O O O O C O
`
`
`
`4 Filing reviews for scientific disciplines are NOT required to be included in the action package.
`
`Version: 5/14/2014
`
`Reference ID: 3520929
`
`

`

`NDAIBLA #
`
`Page 5
`
`°2° Advisory Committee Meeting(s)
`
`0 Date(s) of Meeting(s)
`
`IX No AC meeting
`
`°2° Oflice Director Decisional Memo (indicate datefor each review)
`
`I: None
`
`6/5/14, 5/13/13
`
`Division Director Summary Review (indicate datefor each review)
`
`E] None
`
`6/2/14, 4/24/13
`
`Cross-Discipline Team Leader Review (indicate datefor each review)
`
`D None 4/ 16/13
`
`PMR/PMC Development Templates (indicate total number)
`
`E] None
`
`
`1 - 5/30/14
`
`
`
`°3° Clinical Reviews
`
`_
`_
`_
`.
`.
`.
`Clmrcal Team Leader Revrew(s) (Indicate datefor each rev1ew)
`.
`.
`.
`_
`_
`_
`Clmrcal review(s) (Indicate datefor each let zen.)
`
`
`E] No separate review See
`
`C
`5716/14
`
`4/15/13
`
`
`
`Social scientist review(s) (if OTC drug) (indicate datefor each review)
`
`[Z None
`
`0
`
`0
`
`0
`
`
`
`
`
`
`
`v Fmancral Disclosure rev1ews(s) (allocation/date 1faddressed in another rev1ew
`If no financial disclosure information was required, check here El and include a
`review/memo explaining why not (indicate date ofrevieu-‘lmemo)
`
`4/15/11 p. 13
`
`°2° Clinical reviews from immunology and other clinical areas/divisions/Centers (indicate
`.
`date ofeach rev1ew)
`
`[2 None
`
`°:° Controlled Substance Stafi'review(s) and Scheduling Recommendation (indicate date of
`each review)
`
`IX N/A
`
`02° Risk Management
`0
`REMS Documents and REMS Supporting Docmnent (indicate date(s) of
`submission(s))
`REMS Mc-o(s) and letter(s) (indicate date(s))
`Risk management review(s) and recommendations (including those by OSE and
`CSS) (indicate date ofeach review and indicate location/date ifincorporated
`into another review)
`
`'2' OSI Clinical Inspection Review Summary(ies) (include copies of051 letters to
`im'estigators)
`
`NA
`
`NA
`
`E] None 5/23/14
`
`D None requested 7/2/ 13.
`7/1/13, 6/10/1 3, 3/5/13
`
`°2° Clinical Microbiology Team Leader Review(s) (indicate datefor each review)
`
`IX No separate review
`
`
`
`DNone5/17/l43/4/13
`'
`‘_
`_
`'
`-
`7'
`.
`.
`.
`.
`.
`Climcal Microbiology Revrew(s) (Indicate datefor each I e1- Ieu)
`12/8/12 (mid-cycle)
`
`
`[E No separate review
`
`°:° Statistical Division Director Review(s) (indicate datefor each review)
`
`Statistical Team Leader Review(s) (indicate datefor each review)
`
`IX] No separate review
`
`Statistical Review(s) (indicate datefor each review)
`
`E] None
`
`5/05/14, 3/5/13
`
`
`
`Reference ID: 3520929
`
`Version: 5/14/2014
`
`

`

`NDAIBLA #
`
`Page 6
`
`°3° Clinical Pharmacology Division Director Review(s) (indicate datefor each revieuy
`
`[E No separate review
`
`Clinical Pharmacology Team Leader Review(s) (indicate datefor each review)
`
`Clinical Pharmacology review(s) (indicate datefor each review)
`
`D None
`
`5/6/14, 3/7/13
`
`°3° OSI Clinical Pharmacology Inspection Review Summary (include copies of OSI letters)
`
`D None requested
`
`
`
`
`'30 Pharmacology/1'oxicology Discipline Reviews
`
`0 ADP/T Review(s) (indicate datefor each review)
`
`Supervisory Review(s) (indicate datefor each review)
`
`0
`
`0
`
`I:] No separate review 3/1/13
`
`I:] No separate review 3/5/13
`
`Pharm/tox review(s), including referenced 1ND reviews (indicate datefor each
`review)
`
`D None
`
`5/9/14 3/5/13
`’
`
`02° Review(s) by other disciplines/divisions/Centeis requested by P/'[' reviewer (indicate date
`.
`for each review)
`
`C]
`
`None
`
`'3' Statistical review(s) of carcinogenicity studies (indicate datefor each review)
`
`D No carc
`
`12/6/12
`
`.
`0 ECAC/CAC report/memo ofmeetmg
`°2° OSI Nonclinical Inspection Review Summary (include copies ofOSI letters)
`
`11/30/12
`[I None
`Included in Pff review, page
`I: None requested
`
`°3° Product Quality Discipline Reviews
`
`0 ONDQA/OBP Division Director Review(s) (indicate datefor each review)
`
`E] No separate review 4/12/13
`
`0 Branch Chief/Team Leader Review(s) (indicate datefor each review)
`
`IE No separate review
`
`0
`
`|:]None5/29/145/09/14
`1/10/14 fil'
`. 5/10/13
`ddendum
`.
`.
`.
`.
`.
`.
`.
`Product quality rewew(s) mcludmg ONDQA biopharmaceutics renews (indicate memo) mg
`(a
`datefor each review)
`4/1 1/13 (addendum memo), 3/4/13
`addendum memo . 2/8/13
`
`°3° Microbiology Reviews
`IE NDAs: Microbiology reviews (sterility & pyrogenicity) (OPS/NDMS) (indicate
`date ofeach review)
`I:| BLAs: Sterility assurance. microbiology, facilities reviews
`(0MPQ/MAPCB/BMT) (indicate date ofeach review)
`
`I:] Not needed
`1/13/14
`
`°3° Reviews by other disciplines/divisions/Centers requested by CMC/quality reviewer
`.
`.
`.
`(Indicate date ofeach renew)
`
`IX] None
`
`°3° Environmental Assessment (check one) (original and supplemental applications)
`
`g Categoncal Exclusron (indicate review date)(all original applications and
`all eflicacv supplements that could Increase the patient population)
`
`CMC Review 2/8/13, p. 50
`
`D Review & FONSI (indicate date of review)
`
`I:I Review & Environmental Impact Statement (indicate date ofeach review)
`
`
`
`
`
`
`Reference ID: 3520929
`
`Versiom 5/14/2014
`
`

`

`NDA/BLA #
`
`°2° Facilities Review/Inspection
`
`
`
`
`Page 7
`
`
`
`
`Date completed: 5/27/14
`E NDAs: Facilities inspections (include EER printout or EER Summary Report
`
`only; do NOT include EER Detailed Report: date completed must be within 2
`IX Acceptable
`years of action date) (only original NDAs and supplements that include a new
`I: Withhold recommendation
`facilitv or a change that aflects the manufacturing sitesj)
`I: Not applicable
`
`I:I BLAs: TB-EER (date of most recent TB-EER must be within 30 days of action
`date) (original and supplemental BLAs)
`
`Date completed:
`I: Acceptable
`I: Withhold recommendation
`
`4° NDAs: Methods Validation (check box only, do not include documents)
`
`
`
`
`
`
`
`
`
`IX Completed
`IX Requested
`
`E Not yet requested
`
`E Not needed (per review)
`
`
`
`
`
`
`5 M
`
`i.e., a new facility or a change in the facility. or a change in the manufacturing process in a way that impacts the Quality
`anagement Systems of the facility.
`
`Version: 5/14/2014
`
`Reference ID: 3520929
`
`

`

`NDA/BLA #
`
`Page 8
`
`
`.
`-
`-
`.
`.
`.
`_
`.
`~.° For all 505(b)(2) applications.
`. Check Orange Book for newly listed patents and/or exclusivity (including
`agggigexcmmw (Nonjj
`
`I No changes
`
`pediatric exclusivity)
`
`-
`
`Finalize 505(b)(2) assessment
`
`°3° Send a courtesy copy of approval letter and all attachments to applicant by fax or secure
`email
`
`'2'
`
`If an FDA communication will issue, notify Press Office of approval action afier
`confirming that applicant received comtesy copy of approval letter
`~30 Ensure that proprietary name. if any, and established name are listed in the
`Application Product Names section of DARRTS. and that the proprietary name is
`identified as the ‘ referred” name
`
`0:0 Ensure Pediatric Record is accurate
`
`02° Send approval email within one business day to CDER-APPROVALS
`
`
`D Done
`
`
`
`IE Done
`
`IX Done
`
`IE Done
`
`E Done
`
`IX Done
`
`
`
`
`
`Reference ID: 3520929
`
`Versiom 5/14/2014
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`STROTHER D DIXON
`06/09/2014
`
`Reference ID: 3520929
`
`

`

`From:
`To:
`Cc:
`Subject:
`Date:
`
`Dixon, Strother
`Humphrey, Sean (SHumphrey@dowpharmsci.com)
`Gould, Barbara
`Postmarketing Requirement: NDA 203567 Jublia (efinaconazole) topical solution, 10%
`Friday, May 23, 2014 3:15:00 PM
`
`Greetings. Please refer to your New Drug Application (NDA) submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act for Jublia (efinaconazole) topical
`solution, 10%. The Agency has identified the following postmarketing requirement
`study to be conducted post approval:
`
` A Multicenter, Randomized, Double-Blind Study Evaluating the Safety,
`Efficacy and Pharmacokinetics of Jublia Topical Solution, 10% versus
`Vehicle in Pediatric Subjects ages 12 to 17 years with Onychomycosis of
`the Toenails
`
`
`
`Final Protocol Submission: September 2014
`Study/Trial Completion: March 2018
`Final Report Submission: September 2018
`
`
`Please submit to your NDA by Tuesday, May 27, 2014 confirmation of your proposed
`dates for final protocol submission, study/trial initiation, and final report submission for
`the required postmarketing study.
`
`If you require additional information or have questions, please do not hesitate to
`contact me directly.
`
`Regards,
`Strother
`
`Strother D. Dixon
`Regulatory Health Project Manager
`Division of Dermatology and Dental Products
`Center for Drug Evaluation and Research
`Food and Drug Administration
`E-mail: strother.dixon@fda.hhs.gov
`Phone: 301.796.1015
`Fax: 301.796.9895
`
`Reference ID: 3512421
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`STROTHER D DIXON
`05/23/2014
`
`Reference ID: 3512421
`
`

`

`From:
`To:
`Cc:
`Subject:
`Date:
`Attachments:
`
`Dixon, Strother
`Humphrey, Sean (SHumphrey@dowpharmsci.com)
`Gould, Barbara
`Agency Proposed Labeling: NDA 203567 Jublia (efinaconazole) topical solution, 10%
`Wednesday, May 21, 2014 4:33:00 PM
`Agency Proposed Patient Info Labeling NDA 203567 JUBLIA 20140521.doc
`Agency Proposed Labeling NDA 203567 JUBLIA 20140521.doc
`
`Greetings. Attached, please find the Agency proposed PI and PPI labeling for NDA
`203567 Jublia (efinaconazole) topical solution, 10%. Please submit agreed upon
`labeling to the NDA and provide a courtesy copy of the submission (e.g. labels, 356h
`and cover letter) to me via email by Friday, May 23, 2014.
`
`Please confirm receipt of this email.
`
`If you require additional information or have questions, please do not hesitate to
`contact me directly.
` 
` 
`Regards,
`Strother
`
`Strother D. Dixon
`Regulatory Health Project Manager
`Division of Dermatology and Dental Products
`Center for Drug Evaluation and Research
`Food and Drug Administration
`E-mail: strother.dixon@fda.hhs.gov
`Phone: 301.796.1015
`Fax: 301.796.9895
`
`Reference ID: 3511207
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`STROTHER D DIXON
`05/22/2014
`
`Reference ID: 3511207
`
`

`

`PeRC PREA Subcommittee Meeting Minutes
`April 30, 2014
`
`
`PeRC Members Attending:
`Lynne Yao
`Rosemary Addy
`Jane