CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`022063Orig1s000
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`

`

`ACTION PACKAGE CHECKLIST
`
`NDA # 022063
`BLA #
`
`NDA Supplement #
`BLA Supplement #
`
`IfNDA, Efficacy Supplement Type:
`(an action package is not requiredfor SE8 or SE9 supplements)
`
`Proprietary Name: Mydayis
`.
`.
`.
`.
`_
`Estabhshed/Proper Name. mixed salts ofa Single-entity
`amphetamme product
`Dosa - e Form:
`Ca - sules
`
`.
`.
`Applicant: Shire, LLC.
`Agent for Applicant (ifapplicable): Peggy Sung;
`SUI
`2
`1g@shire.com
`
`RPM: Latrice Wilson, PharmD; latrice.wilson@fda.hhs.gov;
`240402-5317
`
`.
`_
`.
`.
`.
`Divrsron. Psychiatry Products
`For ALL 5051252) applicationsI two months prior to EVERY action:
`
`NDA Application Type: E 505(b)(1) D 505(b)(2)
`Efiicacy Supplement:
`El 505(b)(1) CI 505(b)(2)
`
`BLA Applicatim‘ Type: D 351(k) El 351(3)
`Eflicacy Supplement:
`I:I 351(k)
`I:| 351(a)
`
`. Review the information in the 505(b)(2) Assessment and submit
`the draft2 to CDER 0ND IO for clearance.
`Check Orange Book for newly listed patents and/or
`exclusivity (including pediatric exclusivity)
`
`E] No changes
`I:] New patent/exclusivity (nonfi' CDER 0ND IO)
`Date of check:
`
`Note: Ifpediatric exclusivity has been granted or the pediatric
`information in the labeling ofthe listed drag changed, determine whether
`pediatric information needs to be added to or deletedfrom the labeling of
`this drug.
`
`02° Actions
`
`Proposed action
`0
`0 User Fee Goal Date is June 20 2017
`
`IX AP
`
`D TA
`
`DCR
`
`I:] Received
`
`0
`
`Previous actions (specifi' type and datefor each action taken)
`
`I: None Approvable 5/18/2007
`
`Ifaccelerated approval or approval based on efficacy studies in animals, were promotional
`materials received?
`
`Note: Promotional materials to be used within 120 days after approval must have been
`submitted (for exceptions, see
`hflpzllwww.fda.gov/downloads/Drugs/GuidanceCongplianceReglflatogInfomlation/Guida
`nces/ucn1069965.
`. If not submitted, e «lain
`
`03° Application Characteristics 3
`
`l The Application Infor-ation Section is (only) a checklist. The Contents of Action 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 10 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.
`
`Versiom 05/09/17
`
`Reference ID: 4116124
`
`

`

`NDA 022063
`
`Page 2
`
`[:I Priority
`IX Standard
`Review priority:
`Attention Deficit Hyperactivity Disorder
`Chemical classification (new NDAs only):
`(confirm chemical classification at time ofapproval)
`
`D Fast Track
`I:I Rolling Review
`El Orphan drug designation
`I:| Breakthrough Therapy designation
`0V0”: Set the submission property in DARRITS and notify the CDER Breakthrough Therapy Program Manager;
`Refer to the “RPM 81' Checklistfor Considerations afier Designation Granted”for other required actions: CST SharePoint)
`
`D Rx-to-OTC tun switch
`E] Rx—to-OTC partial switch
`I:I Direct-to-OTC
`
`NDAs: Subpart H
`E] Accelerated approval (21 CFR 3 14.510)
`I:I Restricted distribution (21 CFR 314.520)
`Subpart I
`I:I Approval based on animal studies
`
`BLAs: Subpart E
`I:I Accelerated approval (21 CFR 601.41)
`E] Restricted distribution (21 CFR 601.42)
`SubpartH
`I:I Approval based on animal studies
`
`I:I Submitted in response to a PMR
`I:I Submitted in response to a PMC
`I:I Submitted in response to a Pediatric Written Request
`
`Comments:
`
`REMS: I:I MedGuide
`I:I Communication Plan
`I:] ETASU
`E MedGuide w/o REMS
`[:1 REMS not required
`
`03° BLAs only: Is the product subject to official FDA lot release per 21 CFR 610.2
`(approvals only)
`
`El Yes
`
`[:I No
`
`03° Public communications (approvals only)
`
`0 Oflice of Executive Programs (OEP) liaison has been notified of action
`
`IX Yes D No
`
`
`
`0
`
`Indicate what types (ifany) of information were issued
`
`{0 Exclusivity
`
`X None
`|:] FDA Press Release
`E] FDA Talk Paper
`E] CDER Q&As
`C] Other
`
`0
`
`0
`
`Is approval of this application blocked by any type of exclusivity (orphan, 5-year
`NCE, 3-year, pediatric exclusivity)?
`If so, specifyifythetype
`
`IZNo
`
`[:I Yes
`
`'2' Patent Information (NDAs only)
`
`0
`
`Patent Information:
`Verify that form FDA-3542a was submitted for patents that claim the drug for
`which approval is sought
`
`‘2 Verified
`E] Not applicable because drug is
`an old antibiotic.
`
`'2' List ofoflicers/employees who participated in the decision to approve this application and
`consented to be identified on this list (approvals only)
`
`‘Z In lud d
`c
`e
`
`Documentation of consent/non-consent by officers/employees
`
`IX Included
`
`Reference ID: 4116124
`
`

`

`NDA 022063
`
`Page 3
`
`‘2' Copies of all action letters (including approval letter withfinal labeling)
`
`'3 Package Insert (write submission/communication date at upper right offirstpage ofPI)
`
`0 Most recent drafi labeling (ifit is division-proposed labeling, it should be in
`track—changesformat)
`Original applicant-proposed labeling
`
`'2' Medication Guide/Patient Package Insert/Instructions for Use/Device Labeling (write
`submission/communication date at upper right offirstpage ofeach piece)
`
`Action(s) and date(s):
`Approval 6/20/2017
`Approvable 05/ l 8/2007
`
`X Included
`
`X] Included
`X4 Medication Guide
`[:1 Patient Package Insert
`E] Instructions for Use
`E] Device Labeling
`E] None
`
`0 Most-recent drafi labeling (lfit is division—proposed labeling, it should be in
`track-changesformat)
`0 Original applicant-proposed labeling
`
`[X] Included
`
`[Z Included
`
`
`
`6°
`
`labels (full color carton and immediate-container labels) (write
`submission/communication date on upper right offirstpage ofeach submission)
`0 Most-recent drafl labeling
`
`'3 Proprietary Name
`0 Acceptability/non—acceptability letter(s) (indicate date(s))
`0
`Review(s) (indicate date(s)
`
`‘2'
`
`labeling reviews (indicate dates ofreviews)
`
`IE Included
`
`04/14/2017
`04/13/2017
`
`RPM: X None
`DMEPA: E None 5/18/2017;
`6/19/2017; 6/20/2017
`DMPP/PLT (DRISK):
`E] None 5/30/2017
`OPDP: E] None 05/26/2017;
`5/30/2017
`
`SEALD: E None
`css: E None
`Product Quality E None
`Other: IX None
`
`RPM Filing Review‘l/Memo of Filing Meeting (indicate date ofeach review)
`All NDA 505(b)(2) Actions: Date each action cleared by 505(b)(2) Clearance Committee
`
`N/A
`IX] Not a (b)(2)
`
`Application Integrity Policy (AIP) Status and Related Documents
`http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/default.htm
`
`0 Applicant is on the AIP
`
`I:] Yes E No
`
`4 Filing reviews for scientific disciplines are NOT required to be included in the action package.
`
`Reference ID: 4116124
`
`

`

`NDA 022063
`
`Page 4
`
`0
`
`This application is on the AIP
`
`o
`
`0
`
`Ifyes, Center Director’s Exception for Review memo (indicate date)
`
`Ifyes, 0C clearance for approval (indicate date ofclearance
`communication)
`
`Pediatrics (approvals only)
`0 Date reviewed by PeRC 5/17/2017
`IfPeRC review not necessary, explain:
`
`03° Breakthrough Therapy Designation
`
`O
`
`O
`
`0
`
`Breakthrough Therapy Designation Letter(s) (granted, denied, an/or rescinded)
`
`CDER Medical Policy Council Breakthrough Therapy Designation
`Determination Review Template(s) (include only the completed template(s) and
`not the meetin' minutes)
`
`CDER Medical Policy Council Brief — Evaluating a Breakthrough Therapy
`Designation for Rescission Template(s) (include only the completed template(s)
`and not the meeting minutes)
`
`(completed CDER MPC templates can befound in DARRIS as clinical reviews or on
`the AlPC SharePoint Site
`
`03° Outgoing communications: letters, emails, and faxes considered important to include in
`the action package by the reviewing office/division (e.g., clinical SPA letters, RTF letter,
`Formal Dispute Resolution Request decisional letters, etc.) (do not include OPDP letters
`regarding pre—launch promotional materials as these are non-disclosable; do not include
`Master File letters; do not include previous action letters, as these are located elsewhere
`in package)
`Internal documents: memoranda, telecons, emails, and other documents considered
`'
`rtant to include in the action package by the reviewing office/division (e.g.,
`ato Briefin minutes, Medical Poli Council meetin- minutes
`
`'
`
`Ack Letter: 1/17/20 1 7
`
`Information Requests: 1/17/2017;
`3/13/2017; 5/25/2017;
`PMR: 5/15/201 7
`
`Approval Receipt: 6/20/201 7
`
`O
`0..
`
`0
`0..
`
`El None 4
`
`Minutes of Meetings
`
`0
`
`O
`
`0
`
`Ifnot the first review cycle, any end-of-review meeting (indicate date ofmtg)
`
`IX N/A or no mtg—
`
`Pre-NDA/BLA meeting (indicate date ofmtg)
`
`EOPZ meeting (indicate date ofmtg)
`
`0 Mid-cycle Communication (indicate date ofmtg)
`
`0
`
`Late-cycle Meeting (indicate date ofmtg)
`
`0 Other milestone meetings (e.g., EOP2a, CMC focused milestone meetings)
`(indicate dates 0 mts)
`
`N/A
`
`Advisory Committee Meeting(s)
`
`0 Date(s) of Meeting(s)
`
`No AC meeting
`
`gg 2E
`
`'3' Oflice Director Decisional Memo (indicate datefin' each review)
`
`Division Director Summary Review (indicate datefor each review)
`
`D None
`
`6/19/2017
`
`Cross-Discipline Team Leader Review (indicate datefor each revieuy
`
`E] None
`
`6/19/201 7
`
`PMR/PMC Development Templates (indicate total numbel)
`
`Reference ID: 4116124
`
`

`

`NDA 022063
`
`Page 5
`
`’2' Clinical Reviews
`
`Clinical Team Leader Review(s) (indicate datefor each review)
`
`[Z No separate review
`
`0
`
`0
`
`Clinical review(s) (indicate datefor each review)
`
`Social scientist review(s) (if OTC drug) (indicate datefor each review)
`
`Fmancral Disclosure rev1ews(s) (glimatlon/date ifaddressed ln another rev1ew
`If no financial disclosure information was required, check here I:] and include a
`review/memo explaining why not (indicate date ofreview/memo)
`
`Clinical reviews from immunology and other clinical areas/divisions/Centers (indicate
`date ofeach review)5
`
`6/20/2017
`
`IX None
`
`Clinical review dated 6/20/17
`
`
`
`°2° Controlled Substance Stafi‘review(s) and Scheduling Recommendation (indicate date of
`each review)
`
`|:] N/A 6/14/2017
`
`Risk Management
`0
`REMS Documents and REMS Supporting Document (indicate date(s) of
`submission(s))
`REMS Memo(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 ifincmporated
`into another review)
`
`E] None
`
`'3' OSI Clinical Inspection Review Summary(ies) (include copies of051 letters to
`im‘estigatorzr)
`
`IE Clinical Inspection Summary
`05/11/2017
`
`Clinical Microbiology Team Leader Review(s) (indicate datefor each review)
`Clinical Microbiology Review(s) (indicate datefor each review)
`
`Efigwone See product quahty
`
`°2° Statistical Division Director Review(s) (indicate datefor each review)
`
`E No separate review
`
`Statistical Team Leader Review(s) (indicate datefor each review)
`
`Statistical Review(s) (indicate datefor each review)
`
`E] None
`
`5/ 1 8/201 7
`
`°2° Clinical Pharmacology Division Director Review(s) (indicate datefor each review)
`
`IX No separate review
`
`Clinical Pharmacology Team Leader Review(s) (indicate datefor each review)
`
`Clinical Pharmacology review(s) (indicate datefor each review)
`
`.
`No separate renew
`
`E] None
`
`6/12/2017
`
`°2° 081 Clinical Pharmacology Inspection Review Summary (include copies of081 letters)
`
`IX None requested
`
`5 For Part 3 combination products, all reviews from the reviewing Center(s) should be entered into the official archive (for further
`instructions, see “Section 508 Compliant Documents: Process for Regulatory Project Managers” located in the CST electronic
`repository).
`
`Reference ID: 4116124
`
`

`

`NDA 022063
`
`Page 6
`
`'3' Pharmacology/1'oxicology Discipline Reviews
`
`0 ADP/I Review(s) (indicate datefor each review)
`
`Supervisory Review(s) (indicate datefor each review)
`
`0
`
`0
`
`Pharm/tox review(s), including referenced IND reviews (indicate datefor each
`review
`
`C] None
`
`5,25/2017
`
`[Z No separate review
`
`[Z No separate review
`
`
`
`Review(s) by other disciplines/divisions/Centers requested by PIT reviewer (indicate date
`for each review)
`
`[Z None
`
`Statistical review(s) of carcinogenicity studies (indicate datefor each review)
`
`IX No carc
`
`-
`.0.
`9 ECAC/CAC report/memo ofmeeting
`6° OSI Nonchmcal Inspection Review Summary (include copies of081 letters)
`
`IE None
`Included in PIT review, page
`[Z None requested
`
`°.° Product Quality Disciplme Reviews“
`
`0
`
`0
`
`0
`
`Tertiary rev1ew (indicate datefor each review)
`
`IX None
`
`Secondary revnew (e.g. Branch Chiet) (Indicate datefor each review
`
`I:I None 06/05/2017
`
`Integrated Quality Assessment (contains the Executive Summary and the primary
`reviews fi'om each product quality review discipline) (indicate datefor each
`review)
`
`I:] None
`
`06/05/2017
`
`03° Reviews by other disciplines/divisions/Centers requested by product quality review team
`(indicate date ofeach revieu)
`
`El None
`
`06/05/2017
`
`03° Envnonmental Assessment (check one) (original and supplemental apphcations)
`
`I:I Categorical Exclusion (indicate review date)(all original applications and
`all efi'icacy supplements that could increase the patientpopulation)
`
`El Review & FONSI (indicate date of review)
`
`IX Review & Environmental Impact Statement (indicate date ofeach review)
`
`5/17/2017
`
`6° Facilities Review/Inspection
`
`IX Facilities inspections (indicate date of recommendation; within one week of
`[Z Acceptable' 6/1/2017
`taking an approval action, confirm that there is an acceptable recommendation
`.
`before issuing approval letter) (only original applications and eflicaqv
`supplements thatrequire a manufacturing facility inspection(e.g., newstrength, E :1:gggmmmendauon
`
`.
`
`manufacturingprocess, or manufacturing site change)
`
`6 Do not include Master File (MF) reviews or communications to MF holders. However, these documents should be made available
`upon signatory request.
`
`Reference ID: 4116124
`
`

`

`NDA 022063
`
`Page 7
`
`£0 For all 505(b)(2) applications:
`0 Check Orange Book for newly listed patents and/or exclusivity (including
`pediatric exclusivity)
`
`E] No changes
`E] New patent/exclusivity
`Wotlfil CDER 0M) 10)
`
`
`
`0
`
`Finalize 505(b)(2) assessment
`
`0:- For Breakthrough Therapy (131) Designated drugs:
`0 Noti
`the CDER BT Pro . n Mana ' er
`'20 For products that need to be added to the flush list (generally opioids): Flush List
`'
`the Division of Online Communications, Office of Communications
`0
`°.° Send a courtesy copy of approval letter and all attachments to applicant by fax or
`secure email
`0
`v If an FDA communication will issue, notify Press Office of approval action after
`confirmin- that a licant received courtes co of a uroval letter
`
`°3° 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
`
`03° Ensure Pedialn'c Record is accurate
`
`.
`.
`.
`.
`Send approval ema11w1th1n one busmess day to CDER-APPROVALS
`
`.0
`.0 Take Action Package (if in paper) down to Document Room for scanning within
`two business da 5
`
`D Done
`
`|:| Done
`(Send email to CDER 0ND IO)
`I:I Done
`
`K4 Done
`
`|:I Done
`
`X Done
`
`V
`M Done
`
`bi Done
`
`Reference ID: 4116124
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LATRICE WILSON
`06/23/2017
`
`Reference ID: 4116124
`
`

`

`
`
`Wilson, Latrice
`
`
`
`'om:
`
`uent:
`
`To:
`Subject:
`
`
`
`
`
`Sung, Peggy <psung@shire.com>
`
`
`
`
`
`Tuesday, June 20, 2017 4:19 PM
`
`
`Wilson, Latrice
`
`
`
`
`RE: NDA 022063 Mydayis Approval
`
`
`
`
`
`Categories:
`
`
`
`lsponsor
`
`
`
`Hi Latrice.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Thanks for sendlng the approval letter. I’d like to confirm receipt of the email.
`
`
`
`
`Kind regards.
`
`PeQQV
`
`
`
`
`
`
`
`From: Wilson, Latrice [mailto:Latrice.Wilson@fda.hhs.gov]
`
`
`
`
`
`
`
`Sent: Tuesday, June 20, 2017 4:00 PM
`
`
`
`To: Sung, Peggy
`
`
`
`
`Subject: NDA 022063 Mydayis Approval
`
`
`
`
`
`Hi Peggy,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`The Division has granted approval for NBA 022063, Mydayis (mixed salts of a single—entity amphetamine product)
`
`
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`
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`extended release tablets. Please see attached for a courtesy copy of the approval letter. Official correspondence will be
`received via email.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Please confirm receipt of this email as soon as possible.
`
`Sincerely,
`
`
`
`
`
`
`Latrice M. Wilson, PharmD
`Regulatory Project Manager
`
`
`
`
`
`
`Center for Drug Evaluation & Research
`
`
`
`
`
`Office of Drug Evaluation 1
`
`
`
`
`
`
`
`
`U.S. Food and Drug Administration
`Tel: 240-402—5317
`
`
`latricemilson
`dahhs. ov
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`****************$*****************$*$*t*************$*
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`Shire plc, the ultimate parent of the Shire Group of companies, is registered in Jersey No. 99854
`
`
`
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`Registered Office: 22 Grenville Street, St Helier, Jersey JE4 SPX
`*************$***************$*********************$**
`
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`Please consider the environment before printing this e—mail
`1
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`
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`Reference ID: 4119537
`Reference ID: 4119537
`
`

`

`
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`This email and any files transmitted with it are confidential and
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`may be legally privileged and are intended solely for the use of
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`the individual or entity to whom they are addressed. If you are
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`not the intended recipient please note that any disclosure,
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`distribution, or copying of this email is strictly prohibited and may
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`be unlawfiil. If received in error, please delete this email and any
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`attachments and confirm this to the sender.
`
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`Reference ID: 4119537
`Reference ID: 4119537
`
`
`
`

`

`
`Wilson, Latrice
`
`
`
`
`
`'om:
`
`sent:
`
`To:
`Subject:
`
`
`
`
`
`Sung, Peggy <psung©shire.com>
`
`
`
`
`
`
`Tuesday, June 20, 2017 4:37 PM
`
`
`Wilson, Latrice
`
`
`
`
`
`RE: NDA 022063 Mydayis Approval
`
`
`
`
`
`Categories:
`
`
`
`15ponsor
`
`
`
`Hi Latrice,
`
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`
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`Upon review, Shire has noticed a misspelling in Section 2.4 Dosing lnforrnation (does —) dose). The misspelling will be corrected in the
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`final labels and SPL, which will be submitted to ESG and uploaded to DailyMed within 14 days of approval.
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`Pediatric Use [13 to 17 years!
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`The recommended starting does is 12.5 mg once daily in the morning upon awakening. Dosage may be adjusted in
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`increments of 12.5 mg no sooner than weekly, up to a recommended maximum dose of 25 mg once daily. The dose
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`should be individualized according to the needs and response of the patient. Doses higher than 25 mg have not been
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`evaluated in clinical trials in pediatric patients.
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`Kind regards,
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`P3993!
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`From: Wilson, Latrice |mailto:Latrice.Wilson@fda.hhs.gov|
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`Sent: Tuesday, June 20, 2017 4:00 PM
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`To: Sung, Peggy
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`abject: NDA 022063 Mydayis Approval
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`Hi Peggy,
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`The Division has granted approval for NDA 022063, Mydayis (mixed salts of a single—entity amphetamine product)
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`extended release tablets. Please see attached for a courtesy copy of the approval letter. Official correspondence will be
`received via email.
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`Please confirm receipt of this email as soon as possible.
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`Sincerely,
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`Latrice M. Wilson, PharmD
`Regulatory Project Manager
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`Center for Drug Evaluation 8. Research
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`Office of Drug Evaluation E
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`U.S. Food and Drug Administration
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`Tel: 240-402—531 ‘r'
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`latrice.wilson
`fda.hhs. ov
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`I
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`Reference ID: 4119537
`Reference ID: 4119537
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`*********#***********************************$***$****
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`Shire plc, the ultimate parent of the Shire Group of companies, is registered in Jersey No. 99854
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`Registered Office: 22 Grenville Street, St Helier, Jersey JE4 8PX
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`Please consider the environment before printing this e—mail
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`This email and any files transmitted with it are confidential and
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`may be legally privileged and are intended solely for the use of
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`the individual or entity to whom they are addressed. If you are
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`not the intended recipient please note that any disclosure,
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`distribution, or copying of this email is strictly prohibited and may
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`be unlawful. If received in error, please delete this email and any
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`attachments and confirm this to the sender.
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`Reference ID: 4119537
`Reference ID: 4119537
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`

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`Wilson, Latrice
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`om:
`sent:
`To:
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`Subject
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`Sung, Peggy <psung@shire.com>
`Thursday, June 15, 2017 3:26 PM
`Wilson, Latrice
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`RE: NDA 022063 Mydayis Post Market Requirements
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`Categories:
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`lSponsor
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`Hi Latrioe.
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`Shire agrees to the proposed timelines for the PMRs as well.
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`Kind regards,
`Peggy
`
`From: Wilson, Latrioe [mailtozLatrioe.Wllson@fda.hhs.gov]
`Sent: Thursday, June 15, 2017 3:20 PM
`To: Sung, Peggy
`Subject: RE: NDA 022063 Mydayis Post Market Requirements
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`Hi Peggy.
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`Thanks for confirming our response.
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`In addition to the PMR, does Shire agree to the proposed timelines as well? I know that your internal timelines may be
`ioner, keeping exclusivity in mind, but I wanted to confirm.
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`Sincerely,
`
`Latrice M. Wilson. PharmD
`Regulatory Project Manager
`
`Center for Drug Evaluation 8‘ Research
`Office of Drug Evaluation I
`U.S. Food and Drug Administration
`Tel: 240402-5317
`
`FDA U.S. FOOD & DRUG
`Aommstunow
`
`From: Sung, Peggy [mailto:gsum@shire.oom]
`Sent: Thursday, June 15, 2017 3:10 PM
`To: Wilson, Latrice
`Subject: RE: NDA 022063 Mydayis Post Market Requirements
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`Hi Lattice.
`
`' wanted to send another quick email to confirm that Shire agrees to conducting the studies for the post market requirements in y0ur
`une 13”" email since Shire did not have a teleconfewnce with the Division today.
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`Also. if there is any possibility of accelerating the comments for the container labels. that would really be great.
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`Reference ID: 41 19537
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`1
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`

`

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`Kind regards.
`PeQQY
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`From: Sung, Peggy
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`Sent: Thursday, June 15, 2017 2:46 PM
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`To: 'Wilson, Latrice'
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`Subject: RE: NDA 022063 Mydayis Post Market Requirements
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`Hi Latn‘ce.
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`Thanks very much for the update. Shire will await FDA's comments to the label and med guide this evening.
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`With regards to the Division's responses to Shire’s questions. Shire confirms that enrolling de novo patients into the safety study are in
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`addition to recruiting from the two safety and efficacy trials.
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`Kind regards,
`Peggy
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`From: Wilson, Latrice [mailto:Latrice.Wilson@fda.hhs.gov]
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`Sent: Thursday, June 15, 2017 1:57 PM
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`To: Sung, Peggy
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`Subject: RE: NDA 022063 Mydayis Post Market Requirements
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`Hi Peggy.
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`We have concluded the meeting. The aim is to send the label/med guide to you this evening. Any anticipated changes to
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`the carton/container labels are forthcoming. Hopefully, I will have an update to you by Monday for those.
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`in lieu of a teleconference, the Division has drafted the following responses to your questions:
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`1) Based on prior FDA feedback regarding the consideration of a PWR, Shire submitted a PPSR which now includes a PK study.
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`a safetyi'efficacy study and an open-label safety study. These studies Outlined in the PPSR are generally consistent with the
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`PMR requirements. Further to these 3 studies. FDA has included one additional study in ADHD patients 6-12 years old in the
`PMR communication.
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`a) While we recognize that a formal decision cannot be issued during the teleconference without review from the
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`Pediatric Review Committee (PeRC). Shire would like to propose that these 4 PMR studies be issued as the PWR for
`SHP465 as well as fulfill our PREA requirements. Does FDA agree? Yes.
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`b) Would FDA issue a PWR for the 4 PMR studies without the need for a revised PPSR resubmission? Yes.
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`2) As per the response to FDA’s information request Issued in May 2017 pertaining to the PPSR. Shire committed to submitting a
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`6-month study report as part of an open-label 12 month safety study to provide the requested information in 4-5 year old
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`subjects with ADHD. Shire proposed to submit a 6-month study report by the filing date to satisfy the requirements of the
`PWR.
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`a) A 12-month study report will be submitted by the PMR deadline. Will FDA accept a 6-month study report to fulfill the
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`PWR requirement? Yes. We would accept an interim 6-month study report. We understand that the open-label safety
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`study will be continuing past the timeframe for the PWR.
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`b) Does FDA concur with direct enrollment Into the open-label safety study? Please clarify if enrolling de navo patients
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`into the safety study is in addition to recruiting from the two safety and efficacy trials.
`If so, direct enrollment is
`acceptable.
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`3)
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`In light of the requirement to submit final study reports 15 months prior to expiration of the exclusivity and the projected study
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`timelines, Shire is proposing to submit draft PMR/PWR protocols to FDA as soon as possible following the action date. Would
`FDA be able to commit to a 2-week review timeline of the draft protocols? The Division cannot commit to a 2-week review
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`timeline. We will review the protocols as quickly as possible. but the timeframe will largely depend on our resources at the time
`of submission.
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`Sincerely,
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`Latrice M. Wilson, PharmD
`Regulatory Project Manager
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`Reference ID: 4119537
`Reference ID: 4119537
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`

`

`Center for Drug Evaluation & Research
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`Office of Drug Evaluation l
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`U.S. Food and Drug Administration
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`Tel: 2404026317
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`'1trlce.wilson@fda.hhegov
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`u.s. FOOD & onus
`aommsrnnrrou
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`El *- m
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`fl
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`From: Sung, Peggy [mailto:psung@shire.com]
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`Sent: Thursday, June 15, 2017 10:40 AM
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`To: Wilson, Latrlce
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`Subject: RE: NDA 022063 Mydayis Post Market Requirements
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`Thanks. Latrice. Are you able to share when your labeling meeting is so that Shire's team can internally prepare for standby to
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`promptly address all of FDA's comments? Would there also be any possibility to reserve time with the Division for a teleconference on
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`Friday to review the labeling in order that issues can be quickly addressed?
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`Kind regards.
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`Peggy
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`From: Wilson, Latrioe [mailto:Latrice.Wilson@fda.hhs.gov|
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`Sent: Thursday, June 15, 2017 10:00 AM
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`To: Sung, Peggy
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`Subject: RE: NDA 022063 Mydayis Post Market Requirements
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`Hi Peggy,
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`. received your voicemail. I am currently preparing for the labeling meeting that we have later today. I believe we will
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`respond via email to your questions. I will update you later today.
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`Sincerely,
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`Latrice M. Wilson, PharmD
`Regulatory Project Manager
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`Center for Drug Evaluation 8; Research
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`Office of Drug Evaluation I
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`U.S. Food and Drug Administration
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`Tet: 240-402-5317
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`latrice.wileon@fda.hhs.gov
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`f-DA U.S. FOOD & DRUG
`ADMINISTIAHON
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`From: Wilson, Latrioe
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`sent: Wednesday, June 14, 2017 3:27 PM
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`To: Sung, Peggy
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`Subject: Re: NBA 022063 Mydayis Post Market Requirements
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`.li Peggy,
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`Thank you. I will relay these to my team and will send you an update as soon as possible.
`3
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`Reference ID: 4119537
`Reference ID: 4119537
`
`

`

`Sincerely,
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`Latrice Wilson, PharmD
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`Regulatory Project Manager
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`Division of Psychiatry Products
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`Office of Drug Evaluation I
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`Center For Drug Evaluation and Research, FDA
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`Ph: 240.402.5317
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`Email: latrice.wilson@_fda.hhs.gov
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`
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`From: Sung, Peggy
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`Sent: Wednesday, June 14, 2017 3:23 PM
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`To: Wilson, Latrice
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`Subject: RE: NDA 022063 Mydayis Post Market Requirements
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`Hi Latrice,
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`Please find below Shire's questions pertaining to the post market requirements for NDA 022063.
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`1) Based on prior FDA feedback regarding the consideration of a PWR, Shire submitted a PPSR which now includes a PK study.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`a safetylefficacy study and an open-label safety study. These studies outlined in the PPSR are generally consistent with the
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`
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`
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`
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`
`
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`PMR requirements. Further to these 3 studies, FDA has included one additional study in ADHD patients 6-12 years old in the
`PMR communication.
`
`
`
`
`
`
`
`
`
`
`
`
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`a) While we recognize that a formal decision cannot be issued during the teleconference without review from the
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`Pediatric Review Committee (PeRC), Shire would like to propose that these 4 PMR studies be issued as the PWR for
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`SHP465 as well as fulfill our PREA requirements. Does FDA agree?
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`b) Would FDA issue a PWR for the 4 PMR studies without the need for a revised PPSR resubmission?
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`2) As per the response to FDA’s information request issued in May 2017 pertaining to the PPSR, Shire committed to submitting a
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`6-month study report as part of an open—label 12 month safety study to provide the requested information in 4-5 year old
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`subjects with ADHD. Shire proposed to submit a 6-month study report by the filing date to satisfy the requirements of the
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`7
`PWR.
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`a) A 12—month study report will be submitted by the PMR deadline. Will FDA accept a 6-month study report to fulfill the
`
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`PWR requirement?
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`b) Does FDA concur with direct enrollment into the open-label safety study?
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`3)
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`In light of the requirement to submit final study reports 15 months prior to expiration of the exclusivity and the projected study
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`timelines, Shire is proposing to submit draft PMRIPWR protocols to FDA as soon as possible following the action date. Would
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`FDA be able to commit to a 2-week review timeline of the draft protocols?
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`Shire appreciates any feedback and the potential opportunity for a teleconference to discuss these questions.
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`Kind regards,
`
`Peggy
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`From: Wilson, Latrice [mailto:Latrice.Wilson@fda.hhs.gov]
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`Sent: Wednesday, June 14, 2017 12:44 PM
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`To: Sung, Peggy
`,
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`Subject: RE: NDA 022063 Mydayis Post Market Requirements
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`Hi Peggy,
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`0k, sounds good.
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`As of right now, there may be additional comments concerning the carton and container labels. I’m waiting to hear back
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`on that, as we