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`NDA 209637/S-004
`
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
` Novo Nordisk Inc.
`
` Attention: Stephanie DeChiaro
`
`
` Senior Director, Regulatory Affairs
` P.O. Box 846
`
`
` 800 Scudders Mill Road
`
` Plainsboro, NJ 08536
`
`
`
`Dear Ms. DeChiaro:
`
`
`
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`
`
`
`June 4, 2019, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`
`
`
`Act (FDCA) for Ozempic (semaglutide) injection.
`
`
`
`This Prior Approval supplemental new drug application provides for updates to the
`Instructions for Use (IFU) documents and the carton and container labeling for the 0.25­
`
`0.5 mg and 1 mg (1.5ml) pen injector variants, in order to align the labeling, where
`
`
`
`appropriate, with the labeling that was approved under NDA 209637/S-001.
`
`
`APPROVAL & LABELING
`
`We have completed our review of this application. It is approved, effective on the date of
`
`
`
`this letter, for use as recommended in the enclosed agreed-upon labeling.
`
`
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`
`
`
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`
`
`
`the FDA automated drug registration and listing system (eLIST), as described at
`
`
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`
`
`Prescribing Information, Medication Guide, and Instructions for Use), with the addition of
`
`
`
`any labeling changes in pending “Changes Being Effected” (CBE) supplements, as well
`
`
`as annual reportable changes not included in the enclosed labeling.
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`Reference ID: 4525580
`
`

`

`
`
` NDA 209637/S-004
`
` Page 2
`
`
`Information on submitting SPL files using eList may be found in the guidance for
`
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`Also within 14 days, amend all pending supplemental applications that include labeling
`
`
`changes for this NDA, including CBE supplements for which FDA has not yet issued an
`
`
`
`
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`
`format, that includes the changes approved in this supplemental application, as well as
`
`annual reportable changes. To facilitate review of your submission(s), provide a
`
`
`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
`Word version. The marked-up copy should provide appropriate annotations, including
`
`supplement number(s) and annual report date(s).
`
`
`CARTON AND CONTAINER LABELING
`
`Submit final printed carton and container labeling that are identical to the enclosed
`
`
`carton and container labeling as soon as they are available, but no more than 30 days
`
`after they are printed. Please submit these labeling electronically according to the
`guidance for industry Providing Regulatory Submissions in Electronic Format — Certain
`
`
`
`
`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
`
`Specifications. For administrative purposes, designate this submission “Final Printed
`
`Carton and Container Labeling for approved NDA 209637/S-004.” Approval of this
`
`
`submission by FDA is not required before the labeling is used.
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`
`new active ingredients (which includes new salts and new fixed combinations), new
`
`
`indications, new dosage forms, new dosing regimens, or new routes of administration
`
`
`
`are required to contain an assessment of the safety and effectiveness of the product for
`
`
`
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`
`
`or inapplicable.
`
`
`Because none of these criteria apply to your supplemental application, you are exempt
`
`
`from this requirement.
`
`
`
`PROMOTIONAL MATERIALS
`
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. To do so, submit the following, in triplicate, (1) a cover letter
`
`
`
`
`
`
`
`
`
`
`
`
` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
`
`U.S. Food and Drug Administration
`
`
`
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4525580
`
`

`

`
`
` NDA 209637/S-004
`
` Page 3
`
`
`requesting advisory comments, (2) the proposed materials in draft or mock-up form with
`
`annotated references, and (3) the Prescribing Information to:
`
`
`
`
`
`
`
` OPDP Regulatory Project Manager
`
`Food and Drug Administration
` Center for Drug Evaluation and Research
`
`
` Office of Prescription Drug Promotion (OPDP)
`
` 5901-B Ammendale Road
`
` Beltsville, MD 20705-1266
`
`
`
`
`Alternatively, you may submit a request for advisory comments electronically in eCTD
`
`
`format. For more information about submitting promotional materials in eCTD format,
`
`
`see the draft guidance for industry Providing Regulatory Submissions in Electronic and
`Non-Electronic Format-Promotional Labeling and Advertising Materials for Human
`
`Prescription Drugs.3
`
`You must submit final promotional materials and Prescribing Information, accompanied
`
`
`by a Form FDA 2253, at the time of initial dissemination or publication
`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`
`
`
`
`Instructions for completing the form can be found at FDA.gov.5 For more information
`
`
`about submission of promotional materials to the Office of Prescription Drug Promotion
`
`
`(OPDP), see FDA.gov.6
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 3 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent
`
`
`
` version of a guidance, check the FDA guidance web page at
`
`
`
`
`
` https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
`
` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
`
` 6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4525580
`
`

`

`NDA 209637/S-004
`
`Page 4
`
`
`
`If you have any questions, call Peter Franks, Regulatory Project Manager, at
`
`
`
`(240) 402-4197.
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Lisa B. Yanoff, M.D.
`
`Director (Acting)
`
`Division of Metabolism and Endocrinology Products
`
`Office of Drug Evaluation II
`
`Center for Drug Evaluation and Research
`
`
`
`
`ENCLOSURES:
`
`• Content of Labeling
`
`
`
`o Prescribing Information (version approved April 9, 2019)
`
`
`
`o Medication Guide (version approved December 5, 2017)
`
`
`
`o Instructions for Use (0.25 or 0.5 mg, 1.5 mL)
`
`
`o Instructions for Use (1 mg, 1.5 mL)
`
`
`
`o Instructions for Use (1 mg, 3 mL) (version approved April 9, 2019)
`
`
`
`
`
`
`• Carton and Container Labeling
`
`
`
`
`
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`Reference ID: 4525580
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`LISA B YANOFF
`11/27/2019 11:46:12 AM
`
`Reference ID: 4525580
`
`(
`
`
`
`

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