CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`208700Orig1s000
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`

`

`
`
`ACTION PACKAGE CHECKLIST
`
`
`
`
`APPLICATION INFORMATION
`
`
`
`
`NDA # 208700
`
`BLA #
`
`
`
`
`NDA Supplement #
`
`
`BLA Supplement #
`
`
`
`
`
`
`
`
`If NDA, Efficacy Supplement Type;
`
`
`
`
`
`
`
`
`
`
`(an action package is not requiredfor SE8 or SE9 supplements)
`
`
`
`
`
`
`Proprietary Name: Lutathera
`
`
`
`
`
`luletium Lu 177 dotatate
`Established/Proper Name:
`
`
`
`
`
`
`
`
`Dosage Form: 370 MBq/mL (10 mCi/mL) in single-dose vial
`
`
`
`
`
`
`
`
`Applicant: Advanced Accelerator Applications USA, Inc.
`
`(AAA)
`
`
`
`
`Agent for Applicant (if applicable):
`
`
`
`
`
`
`
`RPM: Nataliya Fesenko
`
`
`
`
`
`Division: DOP2
`
`
`
`
`
`
`
`
`For ALL 505(h112] applications, two months prior to EVERY action:
`
`
`.
`
`
`
`
`
`
`
`
`
`[I 505090)
`NDA Application Type: E 505(b)(l)
`
`
`
`
`
`
`
`Efficacy Supplement:
`El 50503)“) D ”WM” 0 Review the information in the 505(b)(2) Assessment and submit
`
`
`
`
`
`
`
`
`the draft2 to CDER 0ND 10 for clearance.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`0 Check Orange Book for newly listed patents and/0r
`BLA Application TYPE El 3510‘) D 35100
`
`
`
`
`
`
`
`
`
`
`
`
`
`Efficacy Supplement.
`El 351(k) El 351(a)
`exclusivity (including pediatric exclusivity)
`
`
`
`
`
`
`
`
`
`
`
`I] No changes
`
`
`
`
`
`
`[:I New patent/exclusivity (notifiz CDER 0ND I0)
`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.
`
`
`
`
`
`Actions
`
`0
`Proposed action
`
`
`
`
`
`
`
`
`0 User Fee Goal Date is
`
`
`
`
`................................Estimates.£3_1:1§§__2__=..lasagna9.13.m.._Mr.;s____._._._..m_m._..".._s____ m.
`
`
`0
`
`
`
`
`
`
`
`
`
`
`
`
`
`Previous actions (specifiz type and datefor each action taken)
`
`AP
`
`
`
`
`I] TA
`
`
`
`DCR
`
`
`
`
`
`E Lutathera has previously been
`
`
`
`
`
`
`
`
`reviewed under the original NDA
`submissiori that was submitted on
`
`
`
`
`
`
`
`
`
`
`04—27-16 under rolling review with
`
`
`
`
`Priority Review Designation. FDA
`
`
`
`
`issued a Complete Response issued
`
`_ 12/19/2016
`
`
`
`7
`_
`
`
`
`
`
`
`
`
`
`
`
`
`If accelerated 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
`httpsi-‘wwwida.govtdownloads,®ru asiGuidanceComplijnceRgatulatorflnformation/Guida
`
`
`
`
`
`noes: 1191069965.de . If not submitted, exlain
`
`
`
`
`
`
`
`
`
`
`
`
`
`‘2‘
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`' The Application Information 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 drafi 505(b)(2)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Assessment to CDER 0ND IO unless the Assessment has been substantively revised (e.g., new listed drug, patent certification
`
`vised).
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Answer all questions in all sections in relation to the pending application, i.e., if the pending application is anNDA or BLA
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Supplement, then the questions should be answered in relation to that supplement, not in relation to the original NDA or BLA.
`
`
`
`
`
`Version: 1206/”
`
`
`
`
`

`

`NDA 208700
`
`
`Page 2
`
`
`
`
`
`
`
`
`
`
`
`[I Standard E Priority
`Review priority:
`
`
`
`
`
`
`
`
`
`
`
`
`
`Type 1: New Molecular Entity (confirmed with OPQ 1-23—2018)
`Chemical classification (new NDAs only):
`
`
`
`
`
`
`
`(confirm chemical classification at time ofappraval)
`
`
`
`
`
`
`
`
`
`
`
`
`E Fast Track granted 4/21/15 under IND 022719 El Rx-to-OTC full switch
`
`
`
`
`
`
`
`
`
`Rolling Review (see comment below)
`El Rx—to-OTC partial switch
`
`
`
`
`
`E Orphan drug designation
`El Direct-to-OTC
`
`
`
`
`1:] Breakthrough Therapy designation
`
`flVQTE: Set the submission property in DARRTS and notify the CDER Breakthrough Therapy Program Manager;
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Refer to the “RPMBT Checklistfor Considerations afler Designation Granted”for other required actions: 3:; ”T Shari-spam!)
`
`
`
`
`
`
`
`
`
`
`
`
`NDAS: Subpan H
`
`
`
`
`I: Accelerated approval (21 CFR 314.510)
`
`
`
`I] Restricted distribution (21 CFR 314.520)
`
`Subpart 1
`
`
`
`
`
`1:] Approval based on animal studies
`
`
`
`
`
`
`
`
`
`
`
`I] Submitted in response to a PMR
`
`
`
`
`
`
`[:I Submitted in response to a PMC
`
`
`
`
`
`
`
`1:] Submitted in response to a Pediatric Written Request
`
`
`
`
`
`
`BLAs: Subpart E
`
`
`
`
`E] Accelerated approval‘(21 CFR 601.41)
`
`
`
`
`
`I:I Restricted distribution (21 CFR 601.42)
`
`Subpart H
`
`
`
`
`
`I] Approval based on animal studies
`
`
`
`REMS: El MedGuide
`
`
`El Communication Plan
`
`
`[I ETASU
`
`
`
`[:I MedGuide w/o REMS
`
`
`
`
`IE REMS not required
`
`
`
`
`
`
`
`Comments:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Under the original NDA, first review cycle, the NDA was granted a Priority Review Designation and was under Rolling Review.
`
`
`
`
`
`
`
`
`
`This application is a Clan; 2 Resubmission (under 6 months review).
`
`
`
`f
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Is the product subject to official FDA lot release per 21 CFR 610.2
`“ BLAs only:
`
`
`(approvals only)
`'30 Public communications (approvals only) _
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`0 Office of Executive Programs (OEP) liaison has been notified of action
`E Yes D No
`
`None
`
`
`FDA Press Release
`
`
`
`
`
`E] FDA Talk Paper
`
`
`
`I] CDER Q&As
`
`
`
`13 Other
`ASCO Burst
`
`
`
`E] Yes E] No
`
`
`
`
`
`
`
`
`
`
`
`0
`
`
`
`
`
`
`
`
`
`Indicate what types (if any) of information were issued
`
`
`
`
`'30 Exclusivity
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ls approval of this application blocked by any type of exclusivity (orphan, 5—year
`.
`_
`.
`.
`.
`9
`
`
`
`
`NCE, 3 year, pediatric exclusivrty).
`
`
`
`
`
`
`
`
`
`
`
`
`El Yes
`
`
`
`
`
`
`
`
`
`Patent Information:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Verify that form FDA-3542a was submitted for patents that claim the drug for
`
`
`
`
`which approval is sought.
`
`
`
`>11 Verified Form submitted
`
`
`5/1 8/ 16 under the first review
`
`
`
`
`
`
`
`
`
`
`cycle. No form was submitted
`
`
`
`
`
`under the second review cycle.
`
`
`
`
`
`E] Not applicable because drug is
`an old antibiotic.
`
`
`
`
`
`
` a
`
`
`
`
`_0
`
`
`
`
`
`
`
`

`

`NDA 208700
`
`
`Page 3
`
`
`
`
`
`CONTENTS OF ACTION PACKAGE
`
`
`Officer/Employee List
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`‘2‘ List of officers/employees who participated in the decision to approve this application and E Included
`consented to be identified on this list (approvals only) (link)
`I
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Documentation of consent/non-consent by officers!employees (fink)
`
`
`E Included
`
`
`
`
`Action Letters
`
`
`
`
`
`
`
`
`Action(s) and date(s)
`
`
`
`-Approval Letter with final
`
`
`
`labeling issued 01-26-18
`
`
`
`-Comp1ete Response letter without
`
`
`
`labeling issued 12-19-16
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`4‘ Copies of all action letters (including approval letter with final labeling)
`
`
`Labeling
`4° Package Insert (write submission/communication date at upper right offirstpage ofP1) —
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`K4
`Included
`
`
`1-24-18: FDA edits in track-
`
`
`
`
`
`
`
`
`changes format, in response to
`
`
`
`
`Applicant’s label received on
`1-24-1 8
`
`
`
`
`
`
`
`
`
`
`
`
`
`. Most recent draft labeling fifit is division-proposed labeling, it Should be in
`
`
`track-changesformat)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`0 Original applicant-proposed labeling
`
`
`
`
`
`Ellififiiiéd
`
`
`
`32:11:):i::?::3%:u6tf;fled wuh
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`'3' Medication Guide/Patient Package Inserflnstrucdons for Use/Device Labeling (write
`
`
`
`
`
`
`
`
`
`
`
`submisszon/commumcatton date at upper right offirstpage ofeach piece)
`____________________________________________________________________________________________________________________________________________________________________________
`
`
`
`
`
`
`
`
`
`
`
`
`- Most-recent drafi labeling (fit is division-proposed labeling, it should be in
`
`
`track—changesflmat)
`I Original applicant-proposed labeling
`
`
`
`
`
`
`
`
`
`
`
`
`El Instructions for Use
`
`
`I Medication Guide
`
`
`
`
`
`
`CI Patient Package Insert
`
`
`
`
`El Device Labeling
`
`
`
`
`
`None
`
`
`
`I] Included N/A
`
`
`
`
`
`
`t] Included N/A
`
`
`
`
`
`
`
`
`
`
`
`Labels (full color carton and immediate—container labels) (write
`
`
`
`
`
`
`
`
`
`
`
`‘ submission/communication date on upper right affirst page ofeach submission)
`
`
`
`
`
`
`
`
`
`
`
`0' Most-recent draft labeling
`
`
`
`
`
`IXI Included
`
`
`
`Revised Vial label, Container
`
`
`
`
`
`label, and Lead Pot labelling
`received 1/22/18
`
`
`
`
`
`
`
`
`‘20 Proprietary Name
`
`
`
`
`
`I Acceptability/‘non-acceptability letter(s) (indicate dare(s))
`
`
`
`
`Review(s) (indicate date(s)
`0
`
`
`
`
`
`2nd cycle:
`
`
`Conditionally Acceptable Letter
`issued 1-9~18
`
`
`
`
`
`Proprietary Name Review
`
`
`Uploaded 01-08-18
`
`
`1st cycle:
`Conditionally Acceptable Letter
`
`
`
`issued 5-27-16
`
`
`
`
`Proprietary Name Review
`
`
`Uploaded 5—26-16
`
`
`
`04-05—16 IND 077219 Proprie :
`
`
`
`
`
`
`
`
`
`

`

`NDA 1208700
`
`
`Page 4
`
`
`
`
`
`
`
`
`
`
`
`‘2‘ Labeling reviews (indicate dates ofreviews}
`
`
`
`
`
`Administrative I Regulatory Documents
`
`
`
`
`
`
`
`
`
`
`RPM:
`1St Cycle: Review
`
`
`uploaded 6-22-16
`DMEPA:
`
`
`
`2mi cycle:
`01-22-18 TL concurrence 1-22—18
`
`
`
`12-26-17 TL concurrence 12-26-
`
`
`
`17
`
`
`
`
`11—9-17 TL concurrence 11-13-17;
`
`
`
`
`
`1“ cycle: Review uploaded 8-22-
`16 TL concurrence 8-22—16
`
`
`
`
`
`
`DRISK: NIA
`
`
`
`
`
`OPDP: 2le Review cycle: Review
`
`
`uploaded 12-04—17
`
`
`1" cycle: Pre-Decisional Consult
`
`
`
`
`Memo uploaded 11-21-16
`
`
`
`SEALD: E None
`
`
`
`CSS: E None
`
`
`
`
`Product Quality E None
`
`
`
`Other: [I None DPMH review
`
`
`
`
`uploaded 2.”1 cycle: 12-21- 17
`15: c cle: 11-8-16
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`v
`{
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`.
`
`o
`
`o
`
`
`
`
`
`
`Completed ($22-16 for 1‘l review
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`cycle
`0:0 RPM Filing Review‘lMemc of Filing Meeting (indicate date ofeach review)
`'3‘ All NDA 505(b)(2) Actions: Date each action cleared by 505(b)(2) Clearance Committee X Not 3 09(2)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`.
`.
`—
`-
`
`
`
`l £211:gigted 01 25 2018 (D0
`‘3' NDAs/NDA supplements only: Exclu31v1ty Summary (signed by Division Director)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` _.:. Application integrity Policy (AI?) Status and Related Documents
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`llttpilwwu. fdagow’ICECi/EnforcemenL‘kctlonsi’ApplicantsnillteggtyPollcvrdefziult. him
`
`
`
`
`
`
`
`
`
`0 Applicant'is on the AIP
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`This application is on the AIP
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`If yes, Center Director’s Exception for Review memo (indicate date)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`If yes, 0C clearance for approval (indicate date ofclearance
`o
`
`
`
`
`
`
`
`El Not an AP action
`
`communication)
`
`
`
`
`
`
`
`‘9 Pediatrics (approvals only)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`a Date reviewed by PeRC. If PeRC review not necessary, explain: This product in
`
`
`
`
`
`
`
`
`
`
`
`
`this proposed indication was granted orphan drug designation on 5/211'15
`
`
`
`
`
`esinationii0 -2710
`
`
`
`
`
`NIA
`
`
`
`
`
`
`Breakthrough Therapy Designation Letter(s) (granted, denied, anfor rescinded)—
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`CDER Medical Policy Council Breakthrough Therapy Designation
`
`
`
`
`
`
`
`
`
`Determination Review Template(s) (l'ncfua‘e only the compfeted rempiaie(s) and
`
`
`
`
`not the meetin minutes)
`
`
`
`
`
`
`
`
`
`-
`CDER Medical Policy Council Brief— Evaluating a Breakthrough Therapy
`'—
`
`
`
`
`
`
`
`
`Designation for Rescission Tem - late(s)
`include on]
`the completed tem a [are 5)
`
`-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`4 Filing reviews for scientific disciplines are NOT required to be included in the action package.
`
`
`
`

`

`NDA 208700
`
`Page 5
`
`
`
`
`
`
`.
`
`
`
`
`
`
`
`
`
`
`
`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 dccisional letters, etc.) (do not include
`
`
`
`
`
`
`
`
`
`OPDP letters regarding pre—launch promotional maten'als as these are non-
`
`
`
`
`
`
`
`
`
`
`
`
`disclosable; do not include Master File letters; do not include previous action letters,
`
`
`
`
`
`
`
`as these are located elsewhere in package)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`and not the meeting minutes)
`
`
`
`
`
`
`-:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`(completed CDER MPC templates can bejouad in DARRTS as clinical reviews or on
`
`
`
`
`the fig-Elat- (L)
`
`
`
`
`
`01-24-18 Clinical, DMEPA IR
`
`
`
`
`
`1—24-18 FDA modified labeling to
`include additional revisions to P1
`
`
`
`
`
`01-23-18 Clinical IR
`
`
`
`
`
`
`
`
`1—22-18 FDA modified labeling to
`
`include additional revisions to PI
`
`
`
`
`
`
`
`
`
`
`1-19-18 FDA modified labeling to
`
`include additional revisions to P1
`
`
`
`
`
`
`1-17-18 Clinical, DMIP IR
`
`
`
`
`
`
`
`
`
`1-12-18 FDA modified labeling to
`include additional revisions to PI
`
`
`
`
`
`
`
`
`
`1-10-18 Clinical (PMC) IR
`
`
`
`
`1-5-18 Clinical (PMR) [R
`12-27-17 Clinical 1R
`
`
`
`
`
`
`12-27-17 DMEPA (carton and
`
`
`Container) [R
`
`
`
`
`12-19-17 FDA modified labeling
`to include additional revisions to
`
`
`
`
`
`PI
`
`
`
`
`
`12-18-17 Clinical (PMR/PMC
`
`Communication)
`12-5-17 Clinical IR
`
`
`
`
`11-17-17 DMEPA (Carton and
`
`
`Container) IR
`
`
`
`
`11-17-17 FDA modified labeling
`
`
`
`
`
`to include additional revisions to
`
`PI
`
`
`11-16—17 Statistics [R
`
`
`
`
`1 1—14-17 Clinical IR.
`
`
`11-14-17 Acknowledge
`
`
`
`Proprietary Name letter
`
`
`11—13—17 Clinical Pharmacology
`IR
`
`11-8-17 Clinical & Stat IR
`
`
`
`
`
`
`
`
`1 1-7-17 Midcycle Communication,
`
`
`
`letter uploaded 1—16-18
`
`
`11—6-17 Midcycle Agenda
`10—27-17 Statistics IR
`
`
`
`
`10-24-17 Statistics IR
`
`
`
`
`
`
`10—23-17 (1) Clinical [R
`
`
`
`10-23-17 (2) Clinical 1R
`
`
`
`10-11-17 (1) Clinical IR
`
`
`
`10-11-17 (2) Clinical IR
`10-10-17 Statistics IR
`
`
`
`
`
`10—3-17 Clinical Pharmacology
`10-2-17 Clinical IR
`
`
`
`9—28-17 Clinical IR
`
`
`
`9—21-17 Clinical IR
`
`
`
`9-20-17 Clinical IR
`
`
`
`9-14-17 051 [R
`
`
`
`
`
`8-31-17 Clinical IR
`
`
`
`
`
`
`
`8-25-17 Clinical Pharmacology IR
`
`
`
`
`8-25— 1 7 Acknowledge Class '2
`
`Resubmission letter
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`NDA 208700
`
`
`Page 6
`
`
`
`
`
`
`
`
`
`
`8-23-17 Clinical Pharmacology IR
`8-17-17 Statistics IR
`
`
`
`8-14-17 Clinical IR
`
`
`
`
`
`
`
`6-23-17 Stats IR, uploaded 6-26-
`17
`
`6-13-17 Clinical IR
`
`
`6-7-17 Statistics 1R
`
`
`
`
`
`
`
`
`Outgoing Communications under
`
`
`
`first review cycle:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2-10-17 Type A Meeting, Meeting
`
`
`
`Minutes upioadm' 2-13-17
`
`
`
`11-21-16 Discipline Review letter
`9-19-16 CMC IR
`
`
`
`8-16-16 CMC IR
`
`
`
`
`
`
`8—12-16 Clinical Pharmacology IR
`
`
`8-2—16 Mid-Cycle
`
`
`
`Connnunication, letter uploaded 8-
`4-16
`
`7-28-16 CMC IR
`
`
`
`7-21-16 CMC IR
`
`
`
`
`
`
`
`7-18—16 Clinical IR, uploaded 7—
`25-16
`
`7-13-16 OSI FfU IR
`
`
`
`7-11-16 OSI IR
`
`
`
`7-7-16 Clinical/Stats IR
`
`
`7-7-16 Stats F/U 1R
`
`
`7-5-16 Stats IR
`
`
`
`
`
`
`6—30—16 General Correspondence
`
`
`
`
`
`6-23-16 No Filing Issues Identified
`
`
`
`
`Letter with Clinical Pharmacology
`
`
`
`
`IR & Labeling Comments
`6-21-16 Stats/Clinical [R
`
`
`
`6-10-16 Stats IR
`
`
`
`6-9-16 Clinical IR
`
`
`
`6-9—16 Stats FfU IR
`
`
`
`
`
`
`
`6—6-16 Clinical Pharmacology IR
`6—3-16 Clinical/OSI IR
`
`
`
`6—1-16 Stats IR
`
`
`
`5-24-16 OSI IR
`
`
`
`5-23-16 OSI IR
`
`
`
`5-18-16 CMC IR sent via fax
`
`
`
`
`
`
`5-17-16 Form 3542a IR
`
`
`
`
`5—16-16 OSI IR
`
`
`
`
`
`
`5-5—16 IRT/QT IR
`
`
`5—2- 1 6 NBA Acknowledgement
`Letter
`
`4-18- 16 Pre—sub
`
`
`
`
`Acknowledgement Letter uploaded
`in DARRTS
`
`
`
`
`
`01-18—1 8 TCON with Applicant
`
`
`
`
`(PI revisions), minutes uploaded
`01-19-18
`
`
`
`
`1-10-18 Wrap—up Meeting,
`
`
`
`minutes uploaded 1—1 7-18
`
`
`
`
`01-03-13 Monthly Internal Team
`
`
`
`Meetin_, minutes uploaded 01-1 7-
`
`
`
`
`
`
`
`
`
`Internal documents: memoranda, telecons, emails, and other documents considered
`
`
`
`
`
`
`
`
`
`
`
`
`important to include in the action package by the reviewing office/division (e.g.,
`
`
`
`
`
`
`
`
`Regulatory Briefing minutes, Medical Policy Council meeting minutes)
`
`
`
`
`
`‘3’
`
`
`
`
`
`
`
`

`

`NDA 208700
`
`
`Page 7
`
`
`
`'
`
`‘
`
`I
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 18
`
`
`
`
`
`
`12-18—17 Internal labeling meeting
`
`
`
`
`#9, minutes uploaded 01-02-18
`
`
`
`11-13—17 Internal labeling meeting
`
`
`
`
`#7, minutes uploaded 01-04-18
`
`
`
`1 1-08-17 Internal labeling meeting
`
`
`
`
`#5, minutes uploaded 01-04-18
`
`
`
`1 1-08-17 lntemal labeling meeting
`
`
`
`
`#6, minutes uploaded 1—04—18
`
`
`
`1 1-08—17 Internal labeling meeting
`
`
`
`
`#4, minutes uploaded 1-04-18
`
`
`
`11-07—17 Internal labeling meeting
`
`
`
`
`#3, minutes uploaded 11-0 7-1 7
`
`
`
`1 1-06-17 Agenda for Mid—Cycle
`
`
`
`Communication to Applicant
`
`
`
`1 1-03-17 Labeling meeting,
`
`
`
`minutes uploaded 11-07-1 7
`
`
`
`
`10-30-17 Internal Midcycle
`
`
`Summary Meeting, summary
`
`
`
`minutes uploaded 11/21/17
`
`
`
`
`10-] 1-17 Applicant TCO'N
`
`
`
`(Manuiactufing Facilities) held,
`
`
`
`internal minutes uploaded 01-04-
`18
`
`
`
`
`
`10—02-17 Internal Team Meeting
`#1
`
`
`
`
`
`08—24-17 TCON with Applicant
`
`
`
`
`(clin pharm), minutes uploaded 08-
`31—201 7
`
`
`
`
`08-17-17 Planning meeting,
`
`
`
`summary minutes uploaded 09-22—
`1 7
`
`11-21-16 OPDP Pre—Decisional
`
`
`Consult Memo
`
`
`1 1-20-16 DRISK Deferral Review
`
`
`
`Memo
`
`1 1—8-16 DPMH consult memo
`
`
`
`
`
`
`
`10—26-16 TCON with Applicant—
`re CR, uploaded 10-2 7—16
`
`
`
`
`
`
`10-23 - l 7 Internal Team Meeting
`
`
`
`
`#2, minutes uploaded 1-} 6-18
`
`
`
`10-21—16 TCQN with Applicant,
`
`
`
`minutes uploaded 10-24—1 6
`
`
`
`
`9-12—16 Delay in review
`
`
`
`
`completion memo by CDTL
`8—1 8-16 DMIP consult review
`
`
`
`memo
`
`
`
`
`8-11-16 TCON with Applicant,
`
`
`
`minutes uploaded 8—15—16
`
`
`
`7-27—16 Internal Mid-Cycle
`
`
`Summary Meeting, summary
`
`
`
`minutes uploaded 8—10—16
`
`
`
`
`7-12-16 TCON with Applicant,
`
`
`
`Isummary minutes uploaded 7—13-
`
`
`1 6
`
`
`
`
`
`6—30-1 6 TCON with Applicant,
`
`
`
`
`summary minutes uploaded 7-6-16
`
`
`
`
`6-23-16 Priority Review
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`NDA 208700
`
`
`Page 8
`
`
`
`
`
`
`
`
`
`-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Designation Memo
`
`
`
`
`6-8—16 Filing meeting, minutes
`
`
`
`
`
`uploaded 6-1 0—16
`
`
`
`5-17-16 Planning meeting,
`
`
`
`summary minutes uploaded 5-18-
`
`
`
`
`
`
`Minutes of Meetings
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`If not the first review cycle, any end-of—review meeting (indicate date ofmtg)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 2-10-17 Type A Meeting, minutes
`
`
`
`
`
`uploaded 2-13-1 7
`
`
`
`3-14-16 Type Bipre-NDA Meeting
`
`
`
`
`under IND 077219, minutes
`
`
`u u loaded 3-] 7-16
`
`Biogy-itddréamflfj7219; Sponsor:
`
`
`
`
`
`
`
`m 3-2—16 (1“ cycle), October 30,
`
`
`
`_ 2017 (2nd e
`le)
`
`Not held
`
`
`
`
`
`
`
`5-22—1 7 Type B Guidance under
`
`
`
`
`IND 077219, minutes uploaded 6-
`8—1 7
`
`
`
`
`
`
`5-18-17 Type C Guidance Written
`
`
`
`
`
`responses Only under IND 077213
`11-24-15 Type C Advice under
`
`
`
`
`
`IND 077213 minutes uploaded
`
`
`
`
`12—3—15
`
`
`
`
`
`
`8-27-15 Type C Guidance under
`
`
`
`
`IND 077213, minutes uploaded 9-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Pre-NDAI'BLA or BPD Type 4 meeting {indicate date ofmtg)
` -
`
`
`
`
`
`
`0
`EOPZ meeting (indicate date ofmtg)
`
`
`
`
`
`
`
`
`
`
`
`
`
`o Mid-cycle Communication (indicate date afmtg)
`
`o
`Late-cycle Meeting (indicate date ofmtg)
`I
`
`
`
`
`
`
`
`
`
`
`.
`.
`.
`t
`_
`.
`
`
`
`
`
`
`
`
`
`
`
`c Other mllestone meetmgs (e.g., EOP2a, BPD Iype 3, CMC focused milestone
`
`
`
`
`meetings) (indicate dates ofmtgs)
`
`
`
`2—15
`
`

`

`NDA 208700
`
`
`Page 9
`
`
`
`
`
`
`‘1‘ Advisory Committee Meeting(s)
`
`
`
`
`
`
`
`0 Date(s) ofMeeting(s)
`
`
`
`
`
`
`E No AC meeting
`
`
`
`
`
`
`
`
`
`
`
`
`Decisions] and Summary Memos
`
`
`
`
`
`
`
`
`
`
`
`
`°20 Office Director Decisional Memo (indicate datefor each review)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Division Director Summary Review (indicate datefar each review)
`
`-
`
`
`
`
`
`2ml cycle: OD signed
`
`
`
`multidisciplinary review on 01-25-
`18.
`
`
`
`
`
`151 cycle: OD signed
`
`
`
`multidisciplinary review on 12-19-
`
`
`2““ cycle. DD Clinical Addendum
`1-25-18
`
`
`
`
`
`DD signed DARRTS memo 01—
`
`
`
`04-18; multidisciplinary review
`
`
`
`signed on 01—25-18.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1"t cycle: DD signed DARRTS
`
`
`
`memo 12-6- 16; mlfltidisciplinary
`
`
`
`
`
`..___ns}5:.as119_21.9a.1..2..16:19..--..-....
`
`
`
`
`2'1d cycle. CDTL signed
`
`
`
`
`multidisciplinary review on 01-24-
`18.
`
`1;, cycle: CDTL signed
`
`
`
`
`
`
`
`multidisciplinary review on 12-16-
`16.
`
`
`§_ESPN ’1 PMC uploaded 11%
`
`
`
`
`Clinical review(s) (indicate datefor each review)
`
`
`0
`
`
`I
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Clinical Team Leader Review(s) (indicate date for each revievv)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1‘“ cycle: No separate review;
`
`
`
`
`DARRTS memo signed 11-22—16;
`Clinical and Clinical Team Leader
`
`
`
`
`
`
`
`
`signed concurrence in
`
`
`
`multidisciplinary review on 12-16-
`16.
`
`
`
`
`
`
`
`
`
`2nd cycle: No separate review;
`
`
`
`DARRTS memo signed 12—15—
`
`
`
`
`2017; Clinical and Clinical Team
`
`
`
`
`Leader signed concurrence in
`
`
`
`multidisciplinary review on 01-24-
`18.
`
`
`
`
`
`
`1st cycle: No separate review;
`
`
`
`
`DARRTS memo signed 11-22—16;
`Clinical and Clinical Team Leader
`
`
`
`
`
`
`
`
`signed concurrence in
`
`
`
`multidisciplinary review on 12-15-
`
`
`
`
`
`
`
`
`
`
`
`.
`.
`.
`.
`.
`.
`.
`
`
`
`
`
`
`
`
`Cross-Disclplme Team Leader Renew (indicate datefor each revzew)
`
`
`
`
`
`
`
`
`
`
`
`PMR/PMCDevelopment Templates (indicate total number)
`
`
`
`
`
`
`
`
`
`
`'3' Clinical Reviews
`
`
`
`
`Clinical
`
`
`
`
`
`
`
`>14
`
`
`
`
`
`
`
`
`
`2mi cycle: No separate review;
`
`
`
`
`DARRTS memo signed 12-15-17;
`Clinical and Clinical Team Leader
`
`
`
`
`
`
`
`
`signed concurrence in
`
`
`multidisciplinary review on
`0 1-24- 1 8
`
`
`
`
`

`

`NDA 208700
`
`
`
`
`Page 10
`
`
`
`r
`
`0
`
`
`Social scientist review(s) (if OTC drug) (indicate datefor each review)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`'2‘ Financial Disclosure reviews(s) or location/date if addressed in another review
`0R
`
`
`
`
`
`
`
`
`
`
`
`
`If no financial disclosure information was required, check here El and include a
`
`
`
`
`
`
`
`
`review/memo explaining why not {indicate date ofreview/memo)
`
`
`
`
`
`
`
`
`
`
`
`
`
`0? Clinical reviews from immunology and other clinical areas/divisions/Centers (indicate
`'
`5
`
`
`
`
`“We Qfeac" WWW)
`
`
`
`
`
`
`
`E None
`
`
`
`
`
`2“d Review Cycle: See Sections
`
`
`
`
`
`
`8.1.] (page 70) and 8.1.3 (page 90)
`
`
`
`of Multidisciplinary review
`
`
`
`
`
`
`
`lt‘l Review cycle: Financial 7
`Disclosure review in
`
`
`
`Clinical/Statistical section of
`
`
`
`
`
`multidisciplinary review (section
`7.2.2., 13.2 .
`
`
`
`
`El None
`
`
`
`
`2‘“1 cycle: CDER, Division of
`
`
`
`Medical Imaging Products/
`
`
`
`
`Clinical Review uploaded 10—6-17
`1M cycle: CDERJ Division of
`
`
`
`
`
`
`
`
`Medial Imaging Products/ Clinical
`Review 8-18-16
`
`
`lZl NfA
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`'3' Controlled Substance Sniff review(s) and Scheduling Recommendation (indicate date of
`
`
`each review)
`
`
`
`
`
` E None
`
`
`
`
`
` I: None
`
`
`
`
`
`
`2'“i Cycle: Review uploaded 12-8-
`
`
`
`
`
`
`17; TL concurrence 12/10/17
`
`
`
`
`
`
`
`1"t cycle: Review uploaded 11—20—
`
`
`
`
`16; TL concurrence l 1—20716
`
`
`
`
`1"1 cycle:
`
`
`
`
`
`1-24-17 Letters to Investigators (2)
`
`
` v 031 Clinical Inspection Review Smnmarflies) (include copies ofOSI letters to 2nd Review cycle:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`inveS‘iga‘O’S)
`10-7—16 081 Summary Review
`
`
`
`
`
`
`
`
`
`
`
`o
`I
`
`
`
`
`
`
`0:. Risk Management
`
`
`
`
`
`
`
`
`
`I
`REMS Documents and REMS Supporting Document (indicate date(s) of
`
`submission (3))
`
`
`
`
`
`
`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 ifincorporated
`
`
`
`into another review)
`
`
`
`
`
`
`
`None
`
`
`
`
`
`
`
`8—19-16 Letters to Investigators (2)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`’or Part 3 combination products, all reviews from the reviewing Centefls) 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).
`
`

`

`NDA 208700
`
`
`
`
`
`Page II
`
`
`
`
`
`
` E No separate review
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`E None
`Clinical Microbiology .Review(s) (indicate datefor each review)
`
`
`Biostatistics
`
`
`
`
`
`El None
`
`
`
`
`
`
`
`2'“d cycle: No separate review;
`
`
`
`DARRTS memo signed 01—04-18.
`
`
`
`Signed concurrence in
`
`
`
`
`multidisciplinary review on 01-24-
`18
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 0:0 Statistical Division Director Review(s) (indicate datefor each review) 1*t cycle: No separate review;
`
`
`
`
`
`
`
`
`
`
`DARRTS memo signed 1 1-22-16.
`
`
`
`Signed concurrence in
`
`
`multidisciplinary review on
`12/ 1 611 6.
`
`
`
`
`
` 1"t cycle: No separate review;
`
`
`
`
`
`
`
`
`
`
`
`DARRTS memo signed 1 1-22-16.
`
`
`
`Signed concurrence in
`
`
`
`
`multidisciplinary review on 12-15-
`16.
`
`
`
`2nd cycle: No separate review;
`
`
`
`
`DARRTS memo signed 01-03-18.
`
`
`
`
`Signed concurrence in
`
`
`
`
`multidisciplinary review on 01—24-
`
`18
`
`
`
`
`
`
`
`
`
`
` Statistical Review(s) (indicate datefor each review)
`
`
`
`
`
`
`
`lst cycle: No separate review;
`
`
`
`
`
`
`DARRTS memo signed 11-22-16.
`
`
`
`
`Signed concurrence in
`
`
`
`multidisciplinary review on 12—15-
`
`16.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Statistical Team Leader Review(s) (indicate datejbr each review)
`
`
`
`
`
`
`
`E 2““1 cycle: No separate review;
`
`
`
`DARRTS memo signed 01-03-18.
`
`
`
`Signed concurrence in
`
`
`
`multidisciplinary review on 01-24-
`18
`
`
`
`
`
`

`

`NDA 208700
`
`
`Page 12
`
`
`
`
`
`
`Clinical Pharmacology
`
`
`
`
`D None
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`‘3 Clinical Pharmacology Division Director Review(s) (indicate dateflar each review)
`
`
`
`
`
`
`
`
`
`
`
`
`
`Clinical Pharmacology Team Leader Review(s) (indicate date1?)?“ each review)
`
`WWWWWWWW
`
`'
`
`
`
`
`
`
`
`
`Clinical Pharmacology review(s) (indicate datefor each review)
`
`
`
`
`
`
`
`at“
`2’Jd cycle: No separate review;
`
`
`
`DARRTS memo signed 12-08—17.
`
`
`
`Signed concurrence in
`
`
`
`multidisciplinary review on 01—24-
`18.
`
`
`
`
`
`
`
`
`
`
`1“ cycle: No separate review:
`
`
`
`
`DARRTS memo signed 11—21-16.
`
`
`
`Signed concurrence in
`
`
`
`multidisciplinary review on 12-16-
`16.
`
`E 2““ cycle: No separate review;
`
`
`
`DARRTS memo signed 12-08—17.
`
`
`
`Signed concurrence in
`
`
`
`multidisciplinary review on 12-24-
`18.
`
`
`
`
`1,, cycle' No separate review-
`
`
`
`
`
`
`
`
`DARRTS memo signed 11-2l*16.
`
`
`
`Signed concurrence in
`
`
`
`multidisciplinary review on 12-15—
`16.
`
`
`
`
`E 2‘“1 cycle: No separate review;
`
`
`
`DARRTS memo signed 12-08-17.
`
`
`
`Signed concurrence in
`
`
`
`multidisciplinary review on 12-24—
`18.
`
`
`
`
`
`
`
`
`1“' cycle: DARRTS memo signed
`
`
`
`
`11—21-16. Signed concurrence in
`
`
`
`multidisciplinary review on 12-15—
`16.
`
`
`
`
`
`
`
`
`QT lRT Review uploaded 7-7-16
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`'3‘ OSI Clinical Pharmacology Inspection Review Summary (include copies ofOSI letters)
`
`
`
`m None requested
`
`
`
`

`

`NDA 208700
`
`
`Page 13
`
`
`
`
`
`Nonclinical
`
`
`
`
`CI None
`
`
`
`.‘ Pharmacology/Toxicology Discipline Reviews
`
`
`
`
`
`
`
`
`
`
`
`
`
`o ADPfI‘ Review(s) (indicate datejbr each review)
`
`
`
`
`!
`
`
`
`
`
`
`
`Supervisory Review(s) (indicate datefor each review)
`
`
`
`.
`
`
`
`Pharm/tox review(s), including referenced IND reviews (indicate datejbr each
`
`
`
`
`
`
`
`
`
`
`WWW)
`
`
`
`
`
`
`
`
`
`
`E 2”“ cycle: No sepaiide review;
`
`
`
`
`
`DARRTS memo signed 12-14—17.
`
`
`
`Signed concurrence in
`
`
`
`multidisciplinary review on 01-24-
`18
`
`
`Ist cycle' No separate revieW'
`
`
`
`
`
`
`
`
`DARRTS memo signed 11/14/16.
`
`
`
`Signed concurrence in
`
`
`multidisciplinary review on
`12/16! 16.
`
`
`
`
`
`
`E 2‘1d cycle: No separate review;
`
`
`
`DARRT S memo signed 12-14-17.
`
`
`
`Signed concurrence in
`
`
`
`multidisciplinary review on 01-24-
`18
`
`
`
`
`1’“ cycle' No separate review-
`
`
`
`
`
`
`
`
`DARRTS memo signed 11-14-16.
`
`
`
`Signed concurrence in
`
`
`
`multidisciplinary review on 12-15~
`'
`16.
`
`
`
`
`
`
`
`
`
`
`cycle: No separate review;
`
`
`
`
`DARRTS memo signed 12-14-17.
`
`
`
`Signed concurrence in
`
`
`
`multidisciplinary review on 12-24-
`
`18'
`1“ cycle: DARRTS Memo signed
`
`
`
`
`
`
`
`
`
`11-14—16; signed concurrence in
`
`
`
`multidisciplinary review on 12-15-
`16.
`‘
`
`
`
`
`
`
`
`
`
`
`
`
`
`'2' Reviews) by other disciplines/divisions/Centers requested by PIT reviewer {indicate date
`for each review)
`
`
`
`
`7"
`
`
`
`
`
`None El No care
`
`
`
`
`
`
`
`
`
`
`
`
`'3' Statistical review(s) of carcinogenicity studies (indicate datefin" each review) -
`
`@- ECAC/CAC report/memo ofmeeting
`
`
`
`
`
`
`
`
`
`
`
`
`
`0? OSI Nonclinical Inspection Review Summary (include copies of 081 letters)
`
`
`
`
`
`
`
`
`
`
`Elfigcllein PIT review pae
`
`
`
`
`
`
`
`
`E None requested
`
`

`

`NDA 208700
`
`
`
`
`Page 14
`
`
`
`
`
`
`Product Quality
`
`
`
`
`I] None
`
`
`
`
`
`
`
`
`v Product Quality Discipline Reviews“
`
`-
`
`
`
`
`
`
`
`
`
`
`
`
`
`Tertiary review (indicate datejbr each review)
`
`
`
`
`
`
`
`
`
`
`
`
`
`-
`
`
`
`
`
`
`
`
`I
`
`
`
`
`
`
`
`
`
`
`Secondary review (e.g., Branch Chief) (indicate datefbr each review)
`
`
`
`
`
`0
`
`
`
`
`
`
`
`
`
`
`
`
`Integrated Quality Assessment (contains the Executive Summary and the primary
`
`
`
`
`
`
`
`
`
`
`
`reviews from each product quality review discipline) (indicate datefor each
`
`
`review)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reviews by other disciplines/divisions/Centers requested by product quality review team (indicate date ofeach review)
`
`
`
`
`
`
`
`
`0% Environmental Assessment (check one) (original and supplemental applications)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2'“1 cycle: OPQ Integrated
`
`
`
`
`
`
`Quality Assessment final
`Review Date: 12—13-17
`
`
`
`
`
`
`
`1“ cycle: Primary, secondary and
`
`
`
`
`tertiary joint review— final tertiary
`signature 11-22—2016_
`
`
`E 211d cycle: OPQ Integrated
`
`
`
`
`
`
`Quality Assessment final
`Review Date: 12-13-17
`
`
`
`
`
`
`
`
`
`
`
`
`1“t cycle: Primary, secondary and
`
`
`
`
`tertiary joint review— final
`
`
`signature 1 1-22—20 1 6
`
`
`E 2nd cycle: OPQ Integrated
`
`
`
`
`
`
`Quality Assessment final
`Review Date: 12-13-17
`
`
`
`
`
`
`
`1st cycle: Microbiology review 11—
`14—16;CMC TL review 11-18-16
`
`
`
`
`
`
`
`
`
`Microbiolm & CMC: Aproval
`
`
`
`
`
`
`
`
`
`
`
`
`Categorical Exclusion (indicate review date)(all original applications and
`
`
`
`
`
`
`
`
`
`all eficacy supplements that could increase the patient population)
`
`
`
`
`
`
`
`
`
`
`
`[I Review8: FONSI (Indicate date of review)
`
`
`El Review5r. Environmental Impact Statement (indicate ciate ofeach review)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2‘“1 cycle: 1243-17 see OPQ
`
`
`
`Integrated Quality Assessment
`
`final review.
`
`
` lmi cycle: 11-22-16 see page 31 of
`
`
`
`
`
`
`
`
`
`
`
`
`
`the Product Quality review
`
`
`
`(Executive Summary)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`“ Do not include Master File (MF) reviews or communications to MF holders. However, these documents should be made available
`
`
`
`upon signatory request.
`
`
`
`

`

`NDA 208700
`
`
`Page 15
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Facilities inspections (indicate date of recommendation; within one week of
`
`
`
`
`
`
`
`
`
`
`taking an approval action, confirm that there is an acceptable recommendation
`
`
`
`
`
`
`
`
`
`before issuing approval letter) (only original applications and efficacy
`
`
`
`
`
`
`
`
`Supplements that require a manufacturing ficility inspection (e.g., new strength,
`
`
`
`
`
`
`manufacturing process. or manufacturing site change)
`
`
`
` ‘3' Facilities Review/Inspection
`
`
`
`
`
`
`
`
`
`
`
`
`
`iSt cycle: Withhold
`
`recommendation - 11-10-16
`
`
`
`