CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`209637Orig1s000
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`

`

`ACTION PACKAGE CHECKLIST
`
`APPLICATION INFORMATION1
`NDA Supplement #
`If NDA, Efficacy Supplement Type: N/A
`NDA # 209637
`(an action package is not required for SE8 or SE9 supplements)
`BLA Supplement #
`BLA #
`Proprietary Name: Ozempic
`Established/Proper Name: semaglutide
`Dosage Form: injection
`RPM: Peter Franks
`
`Applicant: Novo Nordisk Inc.
`Agent for Applicant (if applicable): N/A
`
`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: DMEP
`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.
`
` Actions
`Proposed action
`
` User Fee Goal Date is December 5, 2017
`Previous actions (specify type and date for each action taken)
`
` 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
` 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: 4191977
`
`

`

`NDA 209637
`Page 2
`
` Priority
` Standard
`Review priority:
`Chemical classification (new NDAs only): Type 1 (New Molecular Entity)
`(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
`
` BLAs only: Is the product subject to official FDA lot release per 21 CFR 610.2
`(approvals only)
` Public communications (approvals only)
` Office of Executive Programs (OEP) liaison has been notified of action
`
`
`
`Indicate what types (if any) of information were issued
`
` 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
`
` 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
` 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: 4191977
`
`

`

`NDA 209637
`
`Page 3
`
`02° Copies ofall action letters (including approval letter withfinal labeling)
`
`fictions: 35%;?3
`
`'2' Package Insert (write submission/communication date at upper right offirstpage ofPI)
`
`0 Most recent draft 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)
`
`0 Most-recent drafi labeling (ifit is dMsion-proposed labeling, it should be in
`track—changesformat)
`
`IX Included
`See labeling attached to approval
`letter
`
`E] Included
`
`X Medication Guide
`CI Patient Package Insert
`IX] Instructions for Use
`E] Device Labeling
`E] None
`IX Included
`See labeling attached to approval
`letter
`
`Other: I:I None
`
`. Original applicant-proposed labeling
`
`X Included
`
`'3' Labels (full color carton and immediate-container labels) (write
`submission/communication date on upper right offirstpage ofeach submission)
`
`Most-recent drafi labeling
`
`_
`_
`.
`.
`.
`.
`0 Acceptabillty/non-acceptabrhty letter(s) (Indicate date(s))
`
`0
`
`Review(s) (indicate date(s)
`
`Labeling reviews (indicate dates ofreviews)
`
`E Included
`See labeling attached to approval
`letter
`
`Conditional approval letters:
`2/27/2017
`
`1133/21/22]52/(I117113/2?” (NDA)
`
`RPM: 4/19/2017
`
`DMEPA: D None 11/24/2017;
`12/1/2017; 12/4/2017
`DMPP/PLT (DRISK): 11/9/2017
`I:I None
`OPDP: I:I None 11/13/2017
`SEALD: E None
`CSS: E None
`Product Quality 7/25/2017; see
`Chapter 2 of integrated quality
`assessment
`
`Reference ID: 4191977
`
`

`

`NDA 209637
`Page 4
`
` RPM Filing Review4/Memo of Filing Meeting (indicate date of each review)
` All NDA 505(b)(2) Actions: Date each action cleared by 505(b)(2) Clearance Committee
`
` NDAs/NDA supplements only: Exclusivity Summary (signed by Division Director)
` Application Integrity Policy (AIP) Status and Related Documents
`http://www fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/default.htm
`
` Applicant is on the AIP
`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)
` Pediatrics (approvals only)
` Date reviewed by PeRC 11/1/2017
`If PeRC review not necessary, explain:
`
` 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)
` 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
`important to include in the action package by the reviewing office/division (e.g.,
`Regulatory Briefing minutes, Medical Policy Council meeting minutes)
` 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)
`
`4/20/2017
`
` Not a (b)(2)
`
` Completed (Do not include)
`
` Yes
`
` No
`
` Yes
`
`
`
` No
`
` Not an AP action
`
` N/A
`
`
`
`
`
`
`
`Included
`
`Included
`
` N/A or no mtg
` No mtg 8/2/2016
` No mtg 6/9/2010
` N/A 6/1/2017
` N/A 9/19/2017
`
`N/A
`
`4 Filing reviews for scientific disciplines are NOT required to be included in the action package.
`
`Reference ID: 4191977
`
`

`

`NDA 209637
`Page 5
`
` Advisory Committee Meeting(s)
` Date(s) of Meeting(s)
`
`Decisional and Summary Memos
` 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
`
` 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)
`
` 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)
`
` and include a
`
` Clinical reviews from immunology and other clinical areas/divisions/Centers (indicate
`date of each review)5
`
` No AC meeting
`10/18/2017
`
` None 12/1/2017
`
` None 12/2/2017
`
` None 12/2/2017
`
` None 12/4/2017 (4)
`
` No separate review
`11/16/2017; 11/27/2017
` None
`See page 447 of Clinical Review;
`11/27/2017
`
`
` None
`
`OBP-Immunogenicity: 9/29/2017
`DPMH: 9/12/2017
`CDRH: 8/29/2017
`CDRH Compliance: 8/10/2017
`Opthalmology: 7/5/2017
`QT-IRT: 5/3/2017
`
` Controlled Substance Staff review(s) and Scheduling Recommendation (indicate date of
`each review)
` 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)
`
`
`
`
` OSI Clinical Inspection Review Summary(ies) (include copies of OSI letters to
`investigators)
`
` N/A
`
`12/5/2016
`
`
`
` None 11/6/2017
`
` None requested
`
`8/1/2017 (Interim Summary)
`11/13/2017 (Final Summary)
`
`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: 4191977
`
`

`

`NDA 209637
`Page 6
`
`Clinical Microbiology
` Clinical Microbiology Team Leader Review(s) (indicate date for each review)
`
` None
`
`Clinical Microbiology Review(s) (indicate date for each review)
`Biostatistics
` Statistical Division Director Review(s) (indicate date for each review)
`Statistical Team Leader Review(s) (indicate date for each review)
`
` None
`
`Statistical Review(s) (indicate date for each review)
`
`Clinical Pharmacology
` None
` 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)
`
` OSI Clinical Pharmacology Inspection Review Summary (include copies of OSI letters)
`Nonclinical
` None
` Pharmacology/Toxicology Discipline Reviews
` ADP/T Review(s) (indicate date for each review)
`Supervisory Review(s) (indicate date for each review)
`
`Pharm/tox review(s), including referenced IND reviews (indicate date for each
`
`review)
` Review(s) by other disciplines/divisions/Centers requested by P/T reviewer (indicate date
`for each review)
` Statistical review(s) of carcinogenicity studies (indicate date for each review)
`
` ECAC/CAC report/memo of meeting
`
` OSI Nonclinical Inspection Review Summary (include copies of OSI letters)
`
` No separate review
` None
`See integrated quality assessment
`
` No separate review
` No separate review
` None
`
`Efficacy statistics:8/11/2017;
`1/25/2017;12/4/2017
`Safety Statistics (CVOT study):
`8/29/2017
`
` No separate review
` No separate review
` None 12/4/2017; 8/22/2017;
`2/1/2017
` None requested
`
` No separate review 12/1/2017
` No separate review
`
` None 8/2/2017; 1/17/2017
`
` None
`
` No carc 11/2/2017
` None 7/27/2017 (memo
`date)
`Included in P/T review, page
` None requested
`
`Reference ID: 4191977
`
`

`

`NDA 209637
`Page 7
`
`Product Quality
` 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)
`
` Reviews by other disciplines/divisions/Centers requested by product quality review team
`(indicate date of each review)
`
` None
`
` None
` None
`
`Drug Product 7/25/2017
`Primary Process: 7/26/2017
`Primary Facilities: 7/23/2017
`Microbiology: 7/25/2017
`Integrated Quality: 7/27/2017
` None
`
` 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)
`
`See chapter 2, integrated quality
`assessment
`
`
` Review & Environmental Impact Statement (indicate date of each review)
`
`
`
` 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)
`
` Acceptable 7/23/2017
`See Integrated Quality Assessment
` 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: 4191977
`
`

`

`NDA 209637
`Page 8
`
`Day of Approval Activities
`
` For all 505(b)(2) applications:
` Check Orange Book for newly listed patents and/or exclusivity (including
`pediatric exclusivity)
`
`Finalize 505(b)(2) assessment
`
` For Breakthrough Therapy (BT) Designated drugs:
` Notify the CDER BT Program Manager
` For products that need to be added to the flush list (generally opioids): Flush List
` Notify the Division of Online Communications, Office of Communications
` Send a courtesy copy of approval letter and all attachments to applicant by fax or
`secure email
` If an FDA communication will issue, notify Press Office of approval action after
`confirming that applicant received courtesy copy of approval letter
` 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
` Ensure Pediatric Record is accurate
`
` Send approval email within one business day to CDER-APPROVALS
` Take Action Package (if in paper) down to Document Room for scanning within
`two business days
`
` No changes
` New patent/exclusivity
`(Notify CDER OND IO)
`
` Done
`
` Done
`(Send email to CDER OND IO)
` Done
`
` Done
`
` Done
`
` Done
`
` Done
`
` Done
`
`Reference ID: 4191977
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`PETER D FRANKS
`12/07/2017
`
`Reference ID: 4191977
`
`

`

`From:
`To:
`Subject:
`Date:
`Attachments:
`
`Franks, Peter
`SDEC (Stephanie DeChiaro)
`RE: NDA 209637 semaglutide injection: Round 2 FDA Comments on IFU
`Friday, December 01, 2017 1:42:00 PM
`image002.png
`
`Hello Stephanie,
`
`The IFUs submitted 11/30/2017 are acceptable. Please submit the final versions to the NDA.
`
`Thanks,
`Pete
`
`From: SDEC (Stephanie DeChiaro) [mailto:sdec@novonordisk.com]
`Sent: Thursday, November 30, 2017 5:41 PM
`To: Franks, Peter <Peter.Franks@fda.hhs.gov>
`Subject: RE: NDA 209637 semaglutide injection: Round 2 FDA Comments on IFU
`
`Hi Pete,
`
`Attached are Novo Nordisk’s response to FDA’s comments on the IFU. We have accepted all
`FDA’s comments and updated the requested figures.
`
`If you have any questions, please let me know.
`
`Thanks,
`Stephanie
`
`From: Franks, Peter [mailto:Peter.Franks@fda.hhs.gov]
`Sent: Thursday, November 30, 2017 1:22 PM
`To: SDEC (Stephanie DeChiaro)
`Subject: NDA 209637 semaglutide injection: Round 2 FDA Comments on IFU
`
`Hello Stephanie,
`
`Please refer to your New Drug Application (NDA 209637), dated December 5, 2016, and received
`December 5, 2016, for semaglutide injection.
`
`Attached are the second round of FDA edits of the draft Instructions For Use (IFU) for both pen
`injectors. We remind you that these edits do not reflect the final regulatory decision for this
`application and that portions of the label are still under review and consideration.
`
`We do not have any further comments on the Medication Guide at this time, and the previous round
`of comments provided by Novo Nordisk are acceptable.
`
`Please accept all FDA edits that you agree with. The document that you return to us should only
`show in tracked changes (1) any new edits you have made to our prior edits and (2) any new edits
`from you unrelated to our prior edits. To help avoid confusion, please delete outdated comments
`and formatting bubbles, and leave only comment and formatting bubbles relevant to this round of
`
`Reference ID: 4189917
`
`

`

`labeling negotiations in the label. When you add a comment bubble, please state "NN response to
`FDA change or NN comment."
`
`We ask that you complete your review and return comments as soon as possible or by 10 am on
`Friday, December 1, 2017. You can return the updated labeling via email as the updated versions
`of the labeling need not be submitted to the NDA until final agreed labeling has been reached.
`
`Please acknowledge receipt of this email and let me know if you have any questions.
`
`Sincerely,
`
`Pete
`
`
`Peter Franks, M.S.
`Regulatory Project Manager
`
`Division of Metabolism and Endocrinology Products
`Center for Drug Evaluation and Research
`Office of Drug Evaluation II
`U.S. Food and Drug Administration
`Tel: 240-402-4197
`Peter.Franks@fda.hhs.gov
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4189917
`
`20 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/TS) immediately following this page
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`PETER D FRANKS
`12/04/2017
`
`Reference ID: 4189917
`
`

`

`From:
`To:
`Subject:
`Date:
`Attachments:
`
`Franks, Peter
`SDEC (Stephanie DeChiaro)
`RE: NDA 209637 semaglutide injection: Round 2 carton/container FDA comments
`Friday, December 01, 2017 1:46:00 PM
`image001.png
`image007.png
`
`Hello Stephanie,
`
`The carton/container pieces submitted on November 30 (via the email below), are acceptable.
`Please submit clean versions of the carton/container pieces to the NDA.
`
`Thanks,
`Pete
`
`
`Peter Franks, M.S.
`Regulatory Project Manager
`
`Division of Metabolism and Endocrinology Products
`Center for Drug Evaluation and Research
`Office of Drug Evaluation II
`U.S. Food and Drug Administration
`Tel: 240-402-4197
`Peter.Franks@fda.hhs.gov
`
`
`
`
`
`
`
`
`
`
`
`
`From: SDEC (Stephanie DeChiaro) [mailto:sdec@novonordisk.com]
`Sent: Thursday, November 30, 2017 4:58 PM
`To: Franks, Peter <Peter.Franks@fda.hhs.gov>
`Subject: RE: NDA 209637 semaglutide injection: Round 2 carton/container FDA comments
`
`Hi Pete,
`
`We have accepted all of FDA’s revisions. Per your instructions, I am attaching a “clean”
`word documents and a PDF proof for the following:
`
`
`· 1 mg container label
`· 1 mg carton
`· 0.25/0.5 mg carton (sample and trade)
`
`
`Please let me know if you were able to receive the e-mail with the 8 attachments.
`
`Thanks,
`Stephanie
`
`
`Reference ID: 4189911
`
`

`

`From: Franks, Peter |mailto:Peter.Franks@fda.hhs.gov]
`Sent: Thursday, November 30, 2017 11:58 AM
`To: SDEC (Stephanie DeChiaro)
`Subject: NDA 209637 semaglutide injection: Round 2 carton/container FDA comments
`
`Hello Stephanie,
`
`Please refer to your New Drug Application (N DA 209637), dated December 5, 2016, and received
`
`December 5, 2016, for semaglutide injection. Below please find the second round of edits to the
`
`carton/container labeling. We will respond to the electronic/pharmacy systems submission
`
`separately. Let me know if you have any questions on the changes below.
`
`We recommend the following be implemented prior to approval of this NDA:
`
`1. Container Label for Pen-injector that Doses 1 mg — To mitigate confusion
`regarding the strength and concentration of semaglutide, remove
`
`M0
`
`2. Carton Labeling for Pen-injector that Doses 0.25 mg or 0.5 mg
`
`a. For added clarity and better readability, revise the following statements:
`
`mm)
`i. Change
`to “I injected my weekly 0.25 mg dose on the
`
`ii.
`
`mm
`
`to “I injected my weekly 0.5 mg dose on the
`
`dates below.”
`
`dates below.”
`
`3. Carton Labeling for Pen-injector that Doses 1 mg
`
`Change
`
`a. For better readability, revise the following statement:
`mm) to ”I injected
`
`APPEARS THIS WAY ON
`ORIGINAL
`
`Please submit the revised ”clean” versions of each labeling piece for the carton and container labels
`
`(i.e., don't submit annotated versions).
`
`We ask that you complete your review and return comments and labeling pieces as soon as possible
`
`or by noon on Friday, December 1, 2017. You can return the updated labeling via email as the
`
`updated versions of the labeling need not be submitted to the NDA until final agreed labeling has
`been reached.
`
`Please acknowledge receipt of this email.
`
`Sincerely,
`
`Pete
`
`Reference ID: 418991 1
`
`

`

`
`
`Peter Franks, M.S.
`Regulatory Project Manager
`
`Division of Metabolism and Endocrinology Products
`Center for Drug Evaluation and Research
`Office of Drug Evaluation II
`U.S. Food and Drug Administration
`Tel: 240-402-4197
`Peter.Franks@fda.hhs.gov
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4189911
`
`27 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/TS) immediately following this page
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`PETER D FRANKS
`12/04/2017
`
`Reference ID: 4189911
`
`

`

`From:
`To:
`Subject:
`Date:
`Attachments:
`
`Franks, Peter
`Stephanie DeChiaro
`NDA 209637 semaglutide injection: PI final comments
`Monday, December 04, 2017 11:30:00 AM
`image001.png
`20171204 FDA Comments PI.docx
`
`Hi Stephanie,
`
`In regards to NDA 209637 semaglutide injection, please see the attached draft PI , which includes
`grammatical edits in section 13. We remind you that these edits do not reflect the final regulatory
`decision for this application.
`
`Please accept the tracked changes and submit a clean version of the PI to the NDA by 2pm today.
`
`Please acknowledge receipt of this email and let me know if you have any questions.
`
`Thanks,
`
`Pete
`
`
`Peter Franks, M.S.
`Regulatory Project Manager
`
`Division of Metabolism and Endocrinology Products
`Center for Drug Evaluation and Research
`Office of Drug Evaluation II
`U.S. Food and Drug Administration
`Tel: 240-402-4197
`Peter.Franks@fda.hhs.gov
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4189811
`
`24 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/TS) immediately following this page
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`PETER D FRANKS
`12/04/2017
`
`Reference ID: 4189811
`
`

`

`From:
`To:
`Subject:
`Date:
`Attachments:
`
`Franks, Peter
`Stephanie DeChiaro
`NDA 209637 semaglutide injection: PI FDA comments Round 5
`Friday, December 01, 2017 1:32:00 PM
`20171201 PI FDA comments Round5.docx
`image001.png
`
`Hello Stephanie,
`
`Attached are the fifth round of FDA edits of the draft PI for NDA 209637 semaglutide injection. We
`remind you that these edits do not reflect the final regulatory decision for this application and that
`portions of the label are still under review and consideration.
`
`Please accept all FDA edits that you agree with. The document that you return to us should only
`show in tracked changes (1) any new edits you have made to our prior edits and (2) any new edits
`from you unrelated to our prior edits. To help avoid confusion, please delete outdated comments
`and formatting bubbles, and leave only comment and formatting bubbles relevant to this round of
`labeling negotiations in the label. When you add a comment bubble, please state "NN response to
`FDA change or NN comment."
`
`We ask that you complete your review and return comments as soon as possible or by EOB today,
`12/1/2017. You can return the updated label via email as the updated versions of the label need
`not be submitted to the NDA until final agreed labeling has been reached.
`
`Please acknowledge receipt of this email and let me know if you have any questions.
`
`Sincerely,
`Pete
`
`
`Peter Franks, M.S.
`Regulatory Project Manager
`
`Division of Metabolism and Endocrinology Products
`Center for Drug Evaluation and Research
`Office of Drug Evaluation II
`U.S. Food and Drug Administration
`Tel: 240-402-4197
`Peter.Franks@fda.hhs.gov
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4189189
`
`24 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/TS) immediately following this page
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`PETER D FRANKS
`12/01/2017
`
`Reference ID: 4189189
`
`

`

`From:
`To:
`Subject:
`Date:
`Attachments:
`
`Franks, Peter
`Stephanie DeChiaro
`NDA 209637 semaglutide injection: Response to Nov 30 submission - EHR system comments
`Friday, December 01, 2017 1:39:00 PM
`image001.png
`
`Hello Stephanie,
`
`In regards to NDA 209637 semaglutide injection, please see the recommendations below in
`response to the submission received on 11/30/2017, pertaining to the electronic/pharmacy
`systems.
`
`We recommend the following be implemented prior to approval of this NDA:
`1. Figure 1 Example Screenshots of How Requested Naming Convention May Appear in an
`EHR – For added clarity and to mitigate any confusion, revise the following statements:
`a. Screenshot Example 1
`i.
`
` Revise “
`” to “Ozempic 0.25 mg or 0.5 mg doses, …”
`
`
`b. Screenshot Example 3
`i. Remove
`
` (i.e., change “
`
`” to “1”).
`
`
`Once these revisions are made, please submit the final version with the screenshots to the NDA.
`
`Please acknowledge receipt of this email and let me know if any questions.
`
`Thanks,
`Pete
`
`
`Peter Franks, M.S.
`Regulatory Project Manager
`
`Division of Metabolism and Endocrinology Products
`Center for Drug Evaluation and Research
`Office of Drug Evaluation II
`U.S. Food and Drug Administration
`Tel: 240-402-4197
`Peter.Franks@fda.hhs.gov
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4189195
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b)
`(4)
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`PETER D FRANKS
`12/01/2017
`
`Reference ID: 4189195
`
`

`

`From:
`To:
`Subject:
`Date:
`Attachments:
`
`Franks, Peter
`Stephanie DeChiaro
`NDA 209637 semaglutide injection: FDA Round 4 PI comments
`Thursday, November 30, 2017 11:39:00 AM
`image001.png
`20171130 FDA Comments Round 4 PI.docx
`
`Hello Stephanie,
`
`Attached are the fourth round of FDA edits of the draft PI for NDA 209637 semaglutide injection.
`We remind you that these edits do not reflect the final regulatory decision for this application and
`that portions of the label are still under review and consideration.
`
`Please accept all FDA edits that you agree with. The document that you return to us should only
`show in tracked changes (1) any new edits you have made to our prior edits and (2) any new edits
`from you unrelated to our prior edits. To help avoid confusion, please delete outdated comments
`and formatting bubbles, and leave only comment and formatting bubbles relevant to this round of
`labeling negotiations in the label. When you add a comment bubble, please state "NN response to
`FDA change or NN comment."
`
`We ask that you complete your review and return comments as soon as possible or by noon
`tomorrow, Dec 1, 2017. You can return the updated label via email as the updated versions of the
`label need not be submitted to the NDA until final agreed labeling has been reached.
`
`Please acknowledge receipt of this email and let me know if you have any questions.
`
`Sincerely,
`
`Pete
`
`
`Peter Franks, M.S.
`Regulatory Project Manager
`
`Division of Metabolism and Endocrinology Products
`Center for Drug Evaluation and Research
`Office of Drug Evaluation II
`U.S. Food and Drug Administration
`Tel: 240-402-4197
`Peter.Franks@fda.hhs.gov
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4188396
`
`24 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/TS) immediately following this page
`
`

`

`----------------------------------------