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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 206321/S-005
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Novo Nordisk, Inc.
`Attention: Patricia Robson
`Senior Manager, Regulatory Affairs
`P.O. Box 846
`800 Scudders Mill Road
`Plainsboro, NJ 08536
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`Dear Ms. Robson:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received November
`30, 2016, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Saxenda (liraglutide) injection, 3 mg.
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`We also refer to our approval letter dated May 22, 2017, which contained the following error in
`the attached REMS Letter for Professional Societies: SAXENDA® REMS was inadvertently
`omitted from the text box.
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`This replacement approval letter incorporates the correction of the error in the attached
`documents. The effective approval date will remain May 22, 2017, the date of the original
`approval letter.
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`This Prior Approval supplemental new drug application proposes modifications to the approved
`risk evaluation and mitigation strategy (REMS) for Saxenda to align the REMS with approved
`changes to the prescribing information (PI).
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`We have completed our review of this supplement application, as amended. It is approved
`effective on the date of this letter.
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`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
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`The REMS for Saxenda was originally approved on December 23, 2014, and the most recent
`modification was approved on February 1, 2016. The REMS consists of a communication plan
`and a timetable for submission of assessments of the REMS. Your proposed modification to the
`REMS consists of changes to the REMS document and REMS materials to align with the
`changes to the Saxenda prescribing information approved with NDA 206321/S-003 on
`September 22, 2016.
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`Reference ID: 4104461
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`NDA 206321/S-005
`Page 2
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`Your proposed modified REMS, submitted on May 3, 2017, and appended to this letter, is
`approved.
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`The timetable for submission of assessments of the REMS remains the same as that approved on
`December 23, 2014.
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`There are no changes to the REMS assessment plan described in our December 23, 2014, letter.
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`We remind you that in addition to the REMS assessments submitted according to the timetable in
`the approved REMS, you must include an adequate rationale to support a proposed REMS
`modification for the addition, modification, or removal of any of goal or element of the REMS,
`as described in section 505-1(g)(4) of the FDCA.
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`We also remind you that you must submit a REMS assessment when you submit a supplemental
`application for a new indication for use as described in section 505-1(g)(2)(A) of the FDCA.
`This assessment should include:
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`a) An evaluation of how the benefit-risk profile will or will not change with the new
`indication;
`b) A determination of the implications of a change in the benefit-risk profile for the current
`REMS;
`c) If the new indication for use introduces unexpected risks: A description of those risks
`and an evaluation of whether those risks can be appropriately managed with the currently
`approved REMS.
`d) If a REMS assessment was submitted in the 18 months prior to submission of the
`supplemental application for a new indication for use: A statement about whether the
`REMS was meeting its goals at the time of that the last assessment and if any
`modifications of the REMS have been proposed since that assessment.
`e) If a REMS assessment has not been submitted in the 18 months prior to submission of the
`supplemental application for a new indication for use: Provision of as many of the
`currently listed assessment plan items as is feasible.
`f) If you propose a REMS modification based on a change in the benefit-risk profile or
`because of the new indication of use, submit an adequate rationale to support the
`modification, including: Provision of the reason(s) why the proposed REMS
`modification is necessary, the potential effect on the serious risk(s) for which the REMS
`was required, on patient access to the drug, and/or on the burden on the health care
`delivery system; and other appropriate evidence or data to support the proposed change.
`Additionally, include any changes to the assessment plan necessary to assess the
`proposed modified REMS. If you are not proposing REMS modifications, provide a
`rationale for why the REMS does not need to be modified.
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`If the assessment instruments and methodology for your REMS assessments are not included in
`the REMS supporting document, or if you propose changes to the submitted assessment
`instruments or methodology, you should update the REMS supporting document to include
`specific assessment instrument and methodology information at least 90 days before the
`assessments will be conducted. Updates to the REMS supporting document may be included in a
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`Reference ID: 4104461
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`

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`NDA 206321/S-005
`Page 3
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`new document that references previous REMS supporting document submission(s) for
`unchanged portions. Alternatively, updates may be made by modifying the complete previous
`REMS supporting document, with all changes marked and highlighted. Prominently identify the
`submission containing the assessment instruments and methodology with the following wording
`in bold capital letters at the top of the first page of the submission:
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`NDA 206321 REMS CORRESPONDENCE
`(insert concise description of content in bold capital letters, e.g.,
`UPDATE TO REMS SUPPORTING DOCUMENT - ASSESSMENT
`METHODOLOGY
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`An authorized generic drug under this NDA must have an approved REMS prior to marketing.
`Should you decide to market, sell, or distribute an authorized generic drug under this NDA,
`contact us to discuss what will be required in the authorized generic drug REMS submission.
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`Prominently identify any submission containing the REMS assessments or proposed
`modifications of the REMS with the following wording in bold capital letters at the top of the
`first page of the submission as appropriate:
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`NDA 206321 REMS ASSESSMENT
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`NEW SUPPLEMENT FOR NDA 206321
`CHANGES BEING EFFECTED IN 30 DAYS
`PROPOSED MINOR REMS MODIFICATION
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`or
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`or
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`NEW SUPPLEMENT FOR NDA 206321
`PRIOR APPROVAL SUPPLEMENT
`PROPOSED MAJOR REMS MODIFICATION
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`or
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`NEW SUPPLEMENT FOR NDA 206321
`PRIOR APPROVAL SUPPLEMENT
`PROPOSED REMS MODIFICATIONS DUE TO SAFETY LABEL CHANGES
`SUBMITTED IN SUPPLEMENT XXX
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`or
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`NEW SUPPLEMENT (NEW INDICATION FOR USE)
`FOR NDA 206321
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`REMS ASSESSMENT
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`PROPOSED REMS MODIFICATION (if included)
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`Reference ID: 4104461
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`REMS REVISIONS FOR NDA 206321
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`NDA 206321/S-005
`Page 4
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`Should you choose to submit a REMS revision, prominently identify the submission containing
`the REMS revisions with the following wording in bold capital letters at the top of the first page
`of the submission:
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`
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`To facilitate review of your submission, we request that you submit your proposed modified
`REMS and other REMS-related materials in Microsoft Word format. If certain documents, such
`as enrollment forms, are only in PDF format, they may be submitted as such, but the preference
`is to include as many as possible in Word format.
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`If you do not submit electronically, please send 5 copies of REMS-related submissions.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Martin White, M.S., Regulatory Project Manager, at
`(240) 402-6018.
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`Sincerely,
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`{See appended electronic signature page}
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`Jennifer Rodriguez Pippins, M.D., M.P.H.
`Deputy Director for Safety
`Division of Metabolism and Endocrinology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`REMS
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`
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`Reference ID: 4104461
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`

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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`JENNIFER R PIPPINS
`05/22/2017
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`Reference ID: 4104461
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