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` NDA APPROVAL
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` NDA 213182
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` NDA 213051/S-001
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`Reference ID: 4547501
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`Novo Nordisk Inc.
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`Attention: Stephanie DeChiaro
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`Senior Director, Regulatory Affairs
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`P.O. Box 846
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`800 Scudders Mill Road
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`Plainsboro, NJ 08536
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`Dear Ms. DeChiaro:
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`Please refer to your new drug application (NDA) dated March 20, 2019, received
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`March 20, 2019, and your amendments, submitted under section 505(b) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for Rybelsus (semaglutide) tablets.
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`Please also refer to your supplemental new drug application (NDA 213051/S-001) dated
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`December 10, 2019, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Rybelsus (semaglutide) tablets.
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`This new drug application provides for the addition of efficacy and safety information to
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`the prescribing information based on clinical data from the PIONEER 6 cardiovascular
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`outcomes trial entitled, “A trial investigating the cardiovascular safety of oral
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`semaglutide in subjects with type 2 diabetes.”
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`The supplemental application provides for the addition of this information to the
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`approved labeling for NDA 213051.
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`APPROVAL & LABELING
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`We have completed our review of these applications, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed agreed-
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`upon labeling.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
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`Highlights of Prescribing Information. This waiver applies to all future supplements
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`containing revised labeling unless we notify you otherwise.
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` NDA 213182
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` NDA 213051/S-001
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`Page 2
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information and Medication Guide) as well as annual reportable changes
`not included in the enclosed labeling. Information on submitting SPL files using eLIST
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` may be found in the guidance for industry SPL Standard for Content of Labeling
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`Technical Qs and As.2
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`The SPL will be accessible via publicly available labeling repositories.
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`Because none of these criteria apply to NDA 213182 and NDA 213051/S-001, you are
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`exempt from this requirement.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. To do so, submit, in triplicate, a cover letter requesting advisory
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`comments, the proposed materials in draft or mock-up form with annotated references,
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`and the Prescribing Information, Medication Guide, and Patient Package Insert (as
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`applicable) to:
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`OPDP Regulatory Project Manager
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4547501
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` NDA 213182
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` NDA 213051/S-001
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`Page 3
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`Alternatively, you may submit a request for advisory comments electronically in eCTD
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`format. For more information about submitting promotional materials in eCTD format,
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`see the draft guidance for industry Providing Regulatory Submissions in Electronic and
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`Non-Electronic Format—Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials,
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`and the Prescribing Information, at the time of initial dissemination or publication,
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`accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
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`Information and Instructions for completing the form can be found at FDA.gov.5 For
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`more information about submission of promotional materials to the Office of Prescription
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`Drug Promotion (OPDP), see FDA.gov.6
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`REPORTING REQUIREMENTS
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` We remind you that you must comply with reporting requirements for an approved NDA
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` (21 CFR 314.80 and 314.81).
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` We have now administratively closed NDA 213182. Therefore, all 15-day alert reports,
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` periodic (including quarterly) adverse drug experience reports, field alerts, annual
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` reports, supplements, promotional materials and other submissions should be
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`addressed to the original NDA 213051 for this drug product, not to NDA 213182. In the
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` future, do not make submissions to this NDA except for the final printed labeling
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` requested above.
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` 3 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent
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` version of a guidance, check the FDA guidance web page at
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` https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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` 6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4547501
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`NDA 213182
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`NDA 213051/S-001
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`Page 4
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`If you have any questions, call Peter Franks, Regulatory Project Manager, at
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`(240) 402-4197.
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`Sincerely,
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`{See appended electronic signature page}
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`Lisa B. Yanoff, M.D.
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`Director (Acting)
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`Division of Metabolism and Endocrinology
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`Products
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`Office of Drug Evaluation II
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`• Content of Labeling
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`o Prescribing Information
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`o Medication Guide
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4547501
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`Signature Page 1 of 1
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`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/
`------------------------------------------------------------
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`LISA B YANOFF
`01/16/2020 03:44:51 PM
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`Reference ID: 4547501
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