`
`
` NDA 209637/S-008
`
`
`
`
`
`
`SUPPLEMENT APPROVAL
`
`
` Novo Nordisk Inc.
`
`
`
` Attention: Trine Kruse
` Director, Regulatory Affairs
`
`
` P.O. Box 846
`
` 800 Scudders Mill Road
`
` Plainsboro, NJ 08536
`
`
`
`
`Dear Ms. Kruse:
`
`
`
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`
`
`
`
`October 15, 2020, and your amendments, submitted under section 505(b) of the
`
`
`
`
`Federal Food, Drug, and Cosmetic Act (FDCA) for Ozempic (semaglutide) injection.
`
`
`
`
`
`
`
`
`This Prior Approval sNDA provides for the following revisions to the Prescribing
`
`Information:
`
`
`
`
`
`
`
`1. Addition of Section 6.3 (Postmarketing Experience) to address a signal
`
`
`concerning hypersensitivity. This change also necessitated revisions to the
`
`Medication Guide.
`
`
`
`
`2. Addition of information to Section 3 (Dosage Forms and Strengths) and Section
`
`16 (How Supplied/Storage and Handling) pertaining to the 3 mL cartridge pen
`
`
`
`
`
`injector previously approved in supplement NDA 209637/S-001 on April 9, 2019.
`
`
`
`
`
`3. Revisions to Section 5.5 (Hypoglycemia with Concomitant Use of Insulin
`
`
`
`Secretagoges or Insulin).
`
`
`
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. 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.
`
`
`
`
`
`Reference ID: 4777532
`
`

`

`
`
`
`
`
` NDA 209637/S-008
` Page 2
`
`
`
` 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 and Medication Guide), 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.
`
`
`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).
`
`
`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 application, you are exempt from this
`
`requirement.
`
`
`PROMOTIONAL MATERIALS
`
`
`
`You may request advisory comments on proposed introductory advertising and
`
`promotional labeling. For information about submitting promotional materials, see the
`
`
`final guidance for industry Providing Regulatory Submissions in Electronic and Non­
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
` 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: 4777532
`
`

`

`
`
`
`
`
`
`
` NDA 209637/S-008
` Page 3
`
`
`
` 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
`
`
`
`
`All promotional materials that include representations about your drug product must be
`
`promptly revised to be consistent with the labeling changes approved in this
`
`
`
`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
`
`
`
`in your promotional materials should include prominent disclosure of the important new
`
`
`safety information that appears in the revised labeling. Within 7 days of receipt of this
`
`
`
`
`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
`
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`Your product is a Part 3 combination product (21 CFR 3.2(e)); therefore, you must also
`
`
`comply with postmarketing safety reporting requirements for an approved combination
`
`product (21 CFR 4, Subpart B). Additional information on combination product
`
`
`
`postmarketing safety reporting is available at FDA.gov.6
`
`
`
`If you have any questions, call Lindsey Kelly, Regulatory Project Manager, at
`
`
`301-837-7654.
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`
`Lisa B. Yanoff, MD
`
`
`Deputy Director (Acting)
`
`Office of Cardiology, Hematology, Endocrinology, and
`
`
`Nephrology
`
`Office of New Drugs
`
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`
` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
`
`
`
` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
` 6 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety­
`
`reporting-combination-products
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`
`
`Reference ID: 4777532
`
`

`

`NDA 209637/S-008
`
`
`Page 4
`
`
`
`ENCLOSURES:
`
`• Content of Labeling
`
`
`o Prescribing Information
`
`
`o Medication Guide
`
`
`Instructions for Use (0.25 or 0.5 mg, 1.5 mL) (version approved November
`
`
`
`
`o
`27, 2019)
`
`Instructions for Use (1 mg, 1.5 mL) (version approved November 27,
`
`
`o
`2019)
`
`Instructions for Use (1 mg, 3 mL) (version approved April 9, 2019)
`
`
`
`o
`
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4777532
`
`

`

`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/
`------------------------------------------------------------
`
`HYON J KWON
`04/12/2021 01:24:09 PM
`Signing on behalf of Lisa Yanoff
`
`Reference ID: 4777532
`
`(
`
`
`
`