CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`209803Orig1s000
`209805Orig1s000
`209806Orig1s000
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`

`

`ACTION PACKAGE CHECKLIST
`
`APPLICATION INFORMATION1
`NDA Supplement #
`If NDA, Efficacy Supplement Type:
`NDA # 209803
`(an action package is not required for SE8 or SE9 supplements)
`BLA Supplement #
`BLA #
`Proprietary Name: Steglatro
`Established/Proper Name: ertugliflozin
`Dosage Form: tablet
`RPM: Elizabeth Godwin
`
`Applicant: Merck Sharpe & Dohme Corporation
`Agent for Applicant (if applicable):
`
`NDA Application Type:
`Efficacy Supplement:
`
` 505(b)(1)
` 505(b)(1)
`
` 505(b)(2)
` 505(b)(2)
`
`BLA Application Type:
`Efficacy Supplement:
`
` 351(k)
` 351(k)
`
` 351(a)
` 351(a)
`
`Division: Metabolism and Endocrinology Products
`For ALL 505(b)(2) applications, two months prior to EVERY action:
`
`• Review the information in the 505(b)(2) Assessment and submit
`the draft2 to CDER OND IO for clearance.
`• Check Orange Book for newly listed patents and/or
`exclusivity (including pediatric exclusivity)
`
` No changes
` New patent/exclusivity (notify CDER OND IO)
`Date of check:
`
`Note: If pediatric exclusivity has been granted or the pediatric
`information in the labeling of the listed drug changed, determine whether
`pediatric information needs to be added to or deleted from the labeling of
`this drug.
`
`(cid:3) Actions
`Proposed action
`•
`• User Fee Goal Date is December 19, 2017
`Previous actions (specify type and date for each action taken)
`•
`(cid:3) 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
`http://www fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida
`nces/ucm069965.pdf). If not submitted, explain
`(cid:3) Application Characteristics 3
`
` AP
`
` TA CR
`
` None
`
` Received
`
`1 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 draft 505(b)(2)
`Assessment to CDER OND 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.
`
`Version: 05/09/17
`
`Reference ID: 4198691
`
`

`

`NDA 209803
`Page 2
`
`Review priority:
` Priority
` Standard
`Chemical classification (new NDAs only): Type 1
`(confirm chemical classification at time of approval)
`
` Fast Track
` Rolling Review
` Orphan drug designation
` Breakthrough Therapy designation
`(NOTE: Set the submission property in DARRTS and notify the CDER Breakthrough Therapy Program Manager;
`Refer to the “RPM BT Checklist for Considerations after Designation Granted” for other required actions: CST SharePoint)
`
` Rx-to-OTC full switch
` Rx-to-OTC partial switch
` Direct-to-OTC
`
`NDAs: Subpart H BLAs: Subpart E
`
` Accelerated approval (21 CFR 314.510)
` Accelerated approval (21 CFR 601.41)
`
` Restricted distribution (21 CFR 314.520)
` Restricted distribution (21 CFR 601.42)
` Subpart I Subpart H
`
` Approval based on animal studies
` Approval based on animal studies
`
` Submitted in response to a PMR REMS:
` Submitted in response to a PMC
` Submitted in response to a Pediatric Written Request
`
`Comments:
`
` MedGuide
` Communication Plan
` ETASU
` MedGuide w/o REMS
` REMS not required
`
`(cid:3) BLAs only: Is the product subject to official FDA lot release per 21 CFR 610.2
`(approvals only)
`(cid:3) Public communications (approvals only)
`• Office of Executive Programs (OEP) liaison has been notified of action
`
`•
`
`Indicate what types (if any) of information were issued
`
`(cid:3) Exclusivity
`Is approval of this application blocked by any type of exclusivity (orphan, 5-year
`•
`NCE, 3-year, pediatric exclusivity)?
`If so, specify the type
`•
`(cid:3) Patent Information (NDAs only)
`
` Yes
`
` No
`
` No
`
` Yes
` None
` FDA Press Release
` FDA Talk Paper
` CDER Q&As
` Other
`
` No
`
`
` Yes
`
`•
`
`Patent Information:
`Verify that form FDA-3542a was submitted for patents that claim the drug for
`which approval is sought.
`
` Verified
` Not applicable because drug is
`an old antibiotic.
`
`CONTENTS OF ACTION PACKAGE
`Officer/Employee List
`(cid:3) List of officers/employees who participated in the decision to approve this application and
`consented to be identified on this list (approvals only)
`Documentation of consent/non-consent by officers/employees
`
` Included
`
` Included
`
`Reference ID: 4198691
`
`

`

`NDA 209803
`Page 3
`
`(cid:3) Copies of all action letters (including approval letter with final labeling)
`
`Action Letters
`
`Labeling
`
`(cid:3) Package Insert (write submission/communication date at upper right of first page of PI)
`
`• Most recent draft labeling (if it is division-proposed labeling, it should be in
`track-changes format)
`
`• Original applicant-proposed labeling
`
`(cid:3) Medication Guide/Patient Package Insert/Instructions for Use/Device Labeling (write
`submission/communication date at upper right of first page of each piece)
`
`• Most-recent draft labeling (if it is division-proposed labeling, it should be in
`track-changes format)
`
`• Original applicant-proposed labeling
`
`(cid:3) Labels (full color carton and immediate-container labels) (write
`submission/communication date on upper right of first page of each submission)
`
`• Most-recent draft labeling
`
`(cid:3) Proprietary Name
`• Acceptability/non-acceptability letter(s) (indicate date(s))
`Review(s) (indicate date(s)
`•
`
`(cid:3) Labeling reviews (indicate dates of reviews)
`
`Administrative / Regulatory Documents
`
`(cid:3) RPM Filing Review4/Memo of Filing Meeting (indicate date of each review)
`(cid:3) All NDA 505(b)(2) Actions: Date each action cleared by 505(b)(2) Clearance Committee
`
`(cid:3) NDAs/NDA supplements only: Exclusivity Summary (signed by Division Director)
`(cid:3) Application Integrity Policy (AIP) Status and Related Documents
`http://www fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/default.htm
`
`Action and date
`Approval, December 19, 2017
`
` Included (refer to labeling
`attached to approval letter)
`
` Included
`
` Medication Guide
` Patient Package Insert
` Instructions for Use
` Device Labeling
` None
` Included (refer to labeling
`attached to approval letter)
`
` Included
`
` Included (refer to labels
`attached to approval letter)
`
`Conditionally Acceptable
`3/27/2017
`Reviews 3/22/2017
`
` 3/1/2017
`RPM:
`DMEPA:
` 11/1/2017, 5/4/2017
`DMPP/PLT (DRISK):
` 11/17/2017
` 11/16/2017
`OPDP:
` None
`SEALD:
`CSS:
` None
` None
`Product Quality
`Other:
` DPMH: 8/25/2017
`
`RPM: 3/1/2017
`
` Not a (b)(2)
`
` Completed (Do not include)
`
`• Applicant is on the AIP
`
` Yes
`
` No
`
`4 Filing reviews for scientific disciplines are NOT required to be included in the action package.
`
`Reference ID: 4198691
`
`

`

`NDA 209803
`Page 4
`
`•
`
`This application is on the AIP
`o If yes, Center Director’s Exception for Review memo (indicate date)
`o If yes, OC clearance for approval (indicate date of clearance
`communication)
`(cid:3) Pediatrics (approvals only)
`• Date reviewed by PeRC 11/01/2017
`If PeRC review not necessary, explain:
`
`(cid:3) Breakthrough Therapy Designation
`
`•
`•
`
`•
`
`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 meeting 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 be found in DARRTS as clinical reviews or on
`the MPC SharePoint Site)
`(cid:3) 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)
`(cid:3) 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)
`(cid:3) Minutes of Meetings
`If not the first review cycle, any end-of-review meeting (indicate date of mtg)
`•
`Pre-NDA/BLA meeting (indicate date of mtg)
`•
`EOP2 meeting (indicate date of mtg)
`•
`• Mid-cycle Communication (indicate date of mtg)
`Late-cycle Meeting (indicate date of mtg)
`•
`• Other milestone meetings (e.g., EOP2a, CMC focused milestone meetings)
`(indicate dates of mtgs)
`(cid:3) Advisory Committee Meeting(s)
`• Date(s) of Meeting(s)
`
`Decisional and Summary Memos
`(cid:3) Office Director Decisional Memo (indicate date for each review)
`
`Division Director Summary Review (indicate date for each review)
`
`Cross-Discipline Team Leader Review (indicate date for each review)
`
`PMR/PMC Development Templates (indicate total number)
`Clinical
`
` No
`
` Not an AP action
`
` Yes
`
`
`
`11/1/2017
`
` N/A
`
`
`
`
`
`
`
`Included
`
`Included
`
` N/A or no mtg
` 9/6/2016
` 12/17/2012
` 6/5/2017
` 9/18/2017
`
`
`
` No AC meeting
`
`
` No separate review
`
` No separate review
`
` 12/13/2017
`
` 2
`
`Reference ID: 4198691
`
`

`

`NDA 209803
`Page 5
`
`(cid:3) Clinical Reviews
`Clinical Team Leader Review(s) (indicate date for each review)
`•
`Clinical review(s) (indicate date for each review)
`•
`Social scientist review(s) (if OTC drug) (indicate date for each review)
`•
`(cid:3) Financial Disclosure reviews(s) or location/date if addressed in another review
` OR
` If no financial disclosure information was required, check here
` review/memo explaining why not (indicate date of review/memo)
`(cid:3) Clinical reviews from immunology and other clinical areas/divisions/Centers (indicate
`date of each review)5
`(cid:3) Controlled Substance Staff review(s) and Scheduling Recommendation (indicate date of
`each review)
`(cid:3) Risk Management
`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 of each review and indicate location/date if incorporated
`into another review)
`(cid:3) OSI Clinical Inspection Review Summary(ies) (include copies of OSI letters to
`investigators)
`
` and include a
`
`•
`•
`
` No separate review
`12/4/2017; 2/16/2017
` None
`See page 55 of clinical review
`dated December 4, 2017
`
` QT/IRT: 6/14/2017
`
` N/A
`
`N/A
`
`N/A
`
` 8/24/2017
`
` 8/18/2017
`
`Clinical Microbiology
`(cid:3) Clinical Microbiology Team Leader Review(s) (indicate date for each review)
`Clinical Microbiology Review(s) (indicate date for each review)
`Biostatistics
`(cid:3) Statistical Division Director Review(s) (indicate date for each review)
`Statistical Team Leader Review(s) (indicate date for each review)
`
` None
`
` None
`
`Statistical Review(s) (indicate date for each review)
`Clinical Pharmacology
` None
`(cid:3) Clinical Pharmacology Division Director Review(s) (indicate date for each review)
`Clinical Pharmacology Team Leader Review(s) (indicate date for each review)
`Clinical Pharmacology review(s) (indicate date for each review)
`(cid:3) OSI Clinical Pharmacology Inspection Review Summary (include copies of OSI letters)
`
` No separate review
` None       
`
` No separate review
` No separate review
` 8/25/2017; 8/15/2017;
`2/17/2017; 2/6/2017
`
` No separate review
` No separate review
` 8/18/2017; 2/6/2017
` 2/17/2017; 2/16/2017
`
`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: 4198691
`
`

`

`NDA 209803
`Page 6
`
`Nonclinical
`(cid:3) Pharmacology/Toxicology Discipline Reviews
`• ADP/T Review(s) (indicate date for each review)
`Supervisory Review(s) (indicate date for each review)
`•
`
` None
`
`•
`
`Pharm/tox review(s), including referenced IND reviews (indicate date for each
`review)
`(cid:3) Review(s) by other disciplines/divisions/Centers requested by P/T reviewer (indicate date
`for each review)
`(cid:3) Statistical review(s) of carcinogenicity studies (indicate date for each review)
`
`(cid:3) ECAC/CAC report/memo of meeting
`
`(cid:3) OSI Nonclinical Inspection Review Summary (include copies of OSI letters)
`Product Quality
`(cid:3) Product Quality Discipline Reviews6
`
` None
`
`•
`
`Tertiary review (indicate date for each review)
`
`•
`•
`
`Secondary review (e.g., Branch Chief) (indicate date for each review)
`Integrated Quality Assessment (contains the Executive Summary and the primary
`reviews from each product quality review discipline) (indicate date for each
`review)
`(cid:3) Reviews by other disciplines/divisions/Centers requested by product quality review team
`(indicate date of each review)
`(cid:3) Environmental Assessment (check one) (original and supplemental applications)
` Categorical Exclusion (indicate review date)(all original applications and
` all efficacy supplements that could increase the patient population)
` Review & FONSI (indicate date of review)
`
` Review & Environmental Impact Statement (indicate date of each review)
`
`(cid:3) Facilities Review/Inspection
` 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 facility inspection(e.g., new strength,
`manufacturing process, or manufacturing site change)
`
` 12/11/2017
` No separate review
` 8/17/2017; 1/4/2017; 8/5/2016;
`10/7/2013; 8/29/2011; 5/23/2011;
`10/30/2009
`
` None
`
` 6/29/2017
` 5/26/2017
`
` None requested
`
` Not applicable
`
` Not applicable
`
` 8/18/2017
`
` None
`
`8/18/2017
`
`
`
`
`
` Acceptable
` Withhold recommendation
` Not applicable
`
`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: 4198691
`
`

`

`NDA 209803
`Page 7
`
`Day of Approval Activities
`
`(cid:3) For all 505(b)(2) applications:
`• Check Orange Book for newly listed patents and/or exclusivity (including
`pediatric exclusivity)
`
`Finalize 505(b)(2) assessment
`•
`(cid:3) For Breakthrough Therapy (BT) Designated drugs:
`• Notify the CDER BT Program Manager
`(cid:3) For products that need to be added to the flush list (generally opioids): Flush List
`• Notify the Division of Online Communications, Office of Communications
`(cid:3) Send a courtesy copy of approval letter and all attachments to applicant by fax or
`secure email
`(cid:3) If an FDA communication will issue, notify Press Office of approval action after
`confirming that applicant received courtesy copy of approval letter
`(cid: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 “preferred” name
`(cid:3) Ensure Pediatric Record is accurate
`
` N/A
` New patent/exclusivity
`(Notify CDER OND IO)
`
` N/A
`
` N/A
`(Send email to CDER OND IO)
` N/A
`
` Done
`
` N/A
`
` Done
`
` Done
`
`(cid:3) Send approval email within one business day to CDER-APPROVALS
`(cid:3) Take Action Package (if in paper) down to Document Room for scanning within
`two business days
`
`Done
`Done
`
`Reference ID: 4198691
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`ELIZABETH R GODWIN
`12/21/2017
`
`Reference ID: 4198691
`
`

`

`ACTION PACKAGE CHECKLIST
`
`APPLICATION INFORMATION1
`NDA Supplement #
`If NDA, Efficacy Supplement Type:
`NDA # 209805
`(an action package is not required for SE8 or SE9 supplements)
`BLA Supplement #
`BLA #
`Proprietary Name: Steglujan
`Established/Proper Name: ertugliflozin and sitagliptin
`Dosage Form: tablet
`RPM: Elizabeth Godwin
`
`Applicant: Merck Sharp & Dohme Corp.
`Agent for Applicant (if applicable):
`
`NDA Application Type:
`Efficacy Supplement:
`
` 505(b)(1)
` 505(b)(1)
`
` 505(b)(2)
` 505(b)(2)
`
`BLA Application Type:
`Efficacy Supplement:
`
` 351(k)
` 351(k)
`
` 351(a)
` 351(a)
`
`Division: Division of Metabolism and Endocrinology Products
`For ALL 505(b)(2) applications, two months prior to EVERY action:
`
`• Review the information in the 505(b)(2) Assessment and submit
`the draft2 to CDER OND IO for clearance.
`• Check Orange Book for newly listed patents and/or
`exclusivity (including pediatric exclusivity)
`
` No changes
` New patent/exclusivity (notify CDER OND IO)
`Date of check:
`
`Note: If pediatric exclusivity has been granted or the pediatric
`information in the labeling of the listed drug changed, determine whether
`pediatric information needs to be added to or deleted from the labeling of
`this drug.
`
`(cid:3) Actions
`Proposed action
`•
`• User Fee Goal Date is December 19, 2017
`Previous actions (specify type and date for each action taken)
`•
`(cid:3) 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
`http://www fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida
`nces/ucm069965.pdf). If not submitted, explain
`(cid:3) Application Characteristics 3
`
` AP
`
` TA CR
`
` None
`
` Received
`
`1 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 draft 505(b)(2)
`Assessment to CDER OND 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.
`
`Version: 05/09/17
`
`Reference ID: 4198692
`
`

`

`NDA 209805
`Page 2
`
`Review priority:
` Priority
` Standard
`Chemical classification (new NDAs only): Type 1 and 4
`(confirm chemical classification at time of approval)
`
` Fast Track
` Rolling Review
` Orphan drug designation
` Breakthrough Therapy designation
`(NOTE: Set the submission property in DARRTS and notify the CDER Breakthrough Therapy Program Manager;
`Refer to the “RPM BT Checklist for Considerations after Designation Granted” for other required actions: CST SharePoint)
`
` Rx-to-OTC full switch
` Rx-to-OTC partial switch
` Direct-to-OTC
`
`NDAs: Subpart H BLAs: Subpart E
`
` Accelerated approval (21 CFR 314.510)
` Accelerated approval (21 CFR 601.41)
`
` Restricted distribution (21 CFR 314.520)
` Restricted distribution (21 CFR 601.42)
` Subpart I Subpart H
`
` Approval based on animal studies
` Approval based on animal studies
`
` Submitted in response to a PMR REMS:
` Submitted in response to a PMC
` Submitted in response to a Pediatric Written Request
`
`Comments:
`
` MedGuide
` Communication Plan
` ETASU
` MedGuide w/o REMS
` REMS not required
`
`(cid:3) BLAs only: Is the product subject to official FDA lot release per 21 CFR 610.2
`(approvals only)
`(cid:3) Public communications (approvals only)
`• Office of Executive Programs (OEP) liaison has been notified of action
`
`•
`
`Indicate what types (if any) of information were issued
`
`(cid:3) Exclusivity
`Is approval of this application blocked by any type of exclusivity (orphan, 5-year
`•
`NCE, 3-year, pediatric exclusivity)?
`If so, specify the type
`•
`(cid:3) Patent Information (NDAs only)
`
` Yes
`
` No
`
` No
`
` Yes
` None
` FDA Press Release
` FDA Talk Paper
` CDER Q&As
` Other
`
` No
`
`
` Yes
`
`•
`
`Patent Information:
`Verify that form FDA-3542a was submitted for patents that claim the drug for
`which approval is sought.
`
` Verified
` Not applicable because drug is
`an old antibiotic.
`
`CONTENTS OF ACTION PACKAGE
`Officer/Employee List
`(cid:3) List of officers/employees who participated in the decision to approve this application and
`consented to be identified on this list (approvals only) (link)
`Documentation of consent/non-consent by officers/employees (link)
`
` Included
`
` Included
`
`Reference ID: 4198692
`
`

`

`NDA 209805
`Page 3
`
`(cid:3) Copies of all action letters (including approval letter with final labeling)
`
`Action(s) and date(s)
`Approval, December 19, 2017
`
`Action Letters
`
`Labeling
`
`(cid:3) Package Insert (write submission/communication date at upper right of first page of PI)
`
`• Most recent draft labeling (if it is division-proposed labeling, it should be in
`track-changes format)
`
`• Original applicant-proposed labeling
`
`(cid:3) Medication Guide/Patient Package Insert/Instructions for Use/Device Labeling (write
`submission/communication date at upper right of first page of each piece)
`
`• Most-recent draft labeling (if it is division-proposed labeling, it should be in
`track-changes format)
`
`• Original applicant-proposed labeling
`
`(cid:3) Labels (full color carton and immediate-container labels) (write
`submission/communication date on upper right of first page of each submission)
`
`• Most-recent draft labeling
`
`(cid:3) Proprietary Name
`• Acceptability/non-acceptability letter(s) (indicate date(s))
`Review(s) (indicate date(s)
`•
`
`(cid:3) Labeling reviews (indicate dates of reviews)
`
`Administrative / Regulatory Documents
`
`(cid:3) RPM Filing Review4/Memo of Filing Meeting (indicate date of each review)
`(cid:3) All NDA 505(b)(2) Actions: Date each action cleared by 505(b)(2) Clearance Committee
`
`(cid:3) NDAs/NDA supplements only: Exclusivity Summary (signed by Division Director)
`(cid:3) Application Integrity Policy (AIP) Status and Related Documents
`http://www fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/default.htm
`
` Included (refer to labeling
`attached to approval letter)
`
` Included
`
` Medication Guide
` Patient Package Insert
` Instructions for Use
` Device Labeling
` None
` Included (refer to labeling
`attached to approval letter)
`
` Included
`
` Included (refer to labels
`attached to approval letter)
`
`02/15/2017
`02/10/2017; 10/06/2016
`
` 03/01/2017
`RPM:
`DMEPA:
` 11/01/2017;
`05/04/2017
`DMPP/PLT (DRISK):
` 12/01/2017
` 11/21/2017
`OPDP:
` None
`SEALD:
`CSS:
` None
` None
`Product Quality
`Other:
` DPMH 08/25/2017
`
`RPM: 03/01/2017
`
` Not a (b)(2)
`
` Completed (Do not include)
`
`• Applicant is on the AIP
`
` Yes
`
` No
`
`4 Filing reviews for scientific disciplines are NOT required to be included in the action package.
`
`Reference ID: 4198692
`
`

`

`NDA 209805
`Page 4
`
`•
`
`This application is on the AIP
`o If yes, Center Director’s Exception for Review memo (indicate date)
`o If yes, OC clearance for approval (indicate date of clearance
`communication)
`(cid:3) Pediatrics (approvals only)
`• Date reviewed by PeRC 11/01/2017
`If PeRC review not necessary, explain:
`
`(cid:3) Breakthrough Therapy Designation
`
`•
`•
`
`•
`
`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 meeting 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 be found in DARRTS as clinical reviews or on
`the MPC SharePoint Site)
`(cid:3) 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)
`(cid:3) 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)
`(cid:3) Minutes of Meetings
`If not the first review cycle, any end-of-review meeting (indicate date of mtg)
`•
`Pre-NDA/BLA meeting (indicate date of mtg)
`•
`EOP2 meeting (indicate date of mtg)
`•
`• Mid-cycle Communication (indicate date of mtg)
`Late-cycle Meeting (indicate date of mtg)
`•
`• Other milestone meetings (e.g., EOP2a, CMC focused milestone meetings)
`(indicate dates of mtgs)
`(cid:3) Advisory Committee Meeting(s)
`• Date(s) of Meeting(s)
`
`Decisional and Summary Memos
`(cid:3) Office Director Decisional Memo (indicate date for each review)
`
`Division Director Summary Review (indicate date for each review)
`
`Cross-Discipline Team Leader Review (indicate date for each review)
`
`PMR/PMC Development Templates (indicate total number)
`Clinical
`
` No
`
` Not an AP action
`
` Yes
`
`
`
`11/1/2017
`
` N/A
`
`
`
`
`
`
`
`Included
`
`Not applicable
`
` N/A
` 09/06/2016
` No mtg
` 06/05/2017
` 09/18/2017
`
`
`
` No AC meeting
`
`
` No separate review
`
` No separate review
`
` 12/13/2017
`
` None
`
`Reference ID: 4198692
`
`

`

`NDA 209805
`Page 5
`
`(cid:3) Clinical Reviews
`Clinical Team Leader Review(s) (indicate date for each review)
`•
`Clinical review(s) (indicate date for each review)
`•
`Social scientist review(s) (if OTC drug) (indicate date for each review)
`•
`
` and include a
`
`(cid:3) Financial Disclosure reviews(s) or location/date if addressed in another review
` OR
` If no financial disclosure information was required, check here
` review/memo explaining why not (indicate date of review/memo)
`(cid:3) Clinical reviews from immunology and other clinical areas/divisions/Centers (indicate
`date of each review)5
`(cid:3) Controlled Substance Staff review(s) and Scheduling Recommendation (indicate date of
`each review)
`(cid:3) Risk Management
`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 of each review and indicate location/date if incorporated
`into another review)
`(cid:3) OSI Clinical Inspection Review Summary(ies) (include copies of OSI letters to
`investigators)
`
`•
`•
`
`Clinical Microbiology
`(cid:3) Clinical Microbiology Team Leader Review(s) (indicate date for each review)
`Clinical Microbiology Review(s) (indicate date for each review)
`Biostatistics
`(cid:3) Statistical Division Director Review(s) (indicate date for each review)
`Statistical Team Leader Review(s) (indicate date for each review)
`
` None
`
` None
`
`Statistical Review(s) (indicate date for each review)
`Clinical Pharmacology
` None
`(cid:3) Clinical Pharmacology Division Director Review(s) (indicate date for each review)
`Clinical Pharmacology Team Leader Review(s) (indicate date for each review)
`
`Clinical Pharmacology review(s) (indicate date for each review)
`
`(cid:3) OSI Clinical Pharmacology Inspection Review Summary (include copies of OSI letters)
`
` No separate review
`12/04/2017; 02/16/2017
` None
`See page 55 of clinical review
`dated December 4, 2017
`
` None
`
` N/A
`
`
`
`
`
` None 08/25/2017
`
` 08/18/2017
`
` No separate review
` None       
`
` No separate review
` No separate review
` 08/28/2017; 08/25/2017;
`02/17/2017
`
` No separate review
` No separate review
` 08/18/2017; 08/07/2017;
`02/07/2017
` 04/17/2017
`
`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: 4198692
`
`

`

`NDA 209805
`Page 6
`
`Nonclinical
`(cid:3) Pharmacology/Toxicology Discipline Reviews
`• ADP/T Review(s) (indicate date for each review)
`Supervisory Review(s) (indicate date for each review)
`•
`
` None
`
`•
`
`Pharm/tox review(s), including referenced IND reviews (indicate date for each
`review)
`
`(cid:3) Review(s) by other disciplines/divisions/Centers requested by P/T reviewer (indicate date
`for each review)
`(cid:3) Statistical review(s) of carcinogenicity studies (indicate date for each review)
`
`(cid:3) ECAC/CAC report/memo of meeting
`
`(cid:3) OSI Nonclinical Inspection Review Summary (include copies of OSI letters)
`Product Quality
`(cid:3) Product Quality Discipline Reviews6
`
` None
`
`•
`
`Tertiary review (indicate date for each review)
`
`•
`•
`
`Secondary review (e.g., Branch Chief) (indicate date for each review)
`Integrated Quality Assessment (contains the Executive Summary and the primary
`reviews from each product quality review discipline) (indicate date for each
`review)
`(cid:3) Reviews by other disciplines/divisions/Centers requested by product quality review team
`(indicate date of each review)
`(cid:3) Environmental Assessment (check one) (original and supplemental applications)
` Categorical Exclusion (indicate review date)(all original applications and
` all efficacy supplements that could increase the patient population)
` Review & FONSI (indicate date of review)
`
` Review & Environmental Impact Statement (indicate date of each review)
`
`(cid:3) Facilities Review/Inspection
` Facilities inspections (indicate date of recommendation; within one week of
`taking an approval action, confirm that there is an acceptable rec