,~t1MC£sll
`
`{ ~ lffll U.S. FOOD & DRUG
`
`\,.,,~~ -
`
`ADMINISTRATION
`
`
`
`
` NDA 209637/S-009
`
`
`
`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 May
`
`
`
`
`28, 2021, 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 addition of a 3rd maintenance dose of Ozempic (2
`
`mg subcutaneously once weekly) (2.68 mg/ml concentration).
`
`
`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.
`
`
`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, Instructions for Use, 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.
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`
`
`Reference ID: 4959644
`
`

`

`
`
`
`
`
` NDA 209637/S-009
`
` 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-009.” 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.
`
`
`
`We are waiving the pediatric study requirement for ages 0 through 9 years (inclusive)
`because necessary studies are impossible or highly impracticable. This is because
`
`there are too few children in this age range with type 2 diabetes mellitus to study.
`
`
`We are deferring submission of your pediatric study for ages 10 to 17 years (inclusive)
`
`for this application because this product is ready for approval for use in adults and the
`
`
`
`pediatric study has not been completed.
`
`
`
`
`Your deferred pediatric study required by section 505B(a) of the FDCA is a required
`
` 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: 4959644
`
`
`
`

`

`
`
`
`
`
` NDA 209637/S-009
`
` Page 3
`
`
` postmarketing study. The status of this postmarketing study must be reported annually
`
`according to 21 CFR 314.81 and section 505B(a)(4)(C) of the FDCA. This required
`study is listed below.
`
`
`
`
`
`
`
` 4246-1 Conduct a 52-week, randomized, double-blind, placebo-controlled parallel
`
`
`
` group study of the safety and efficacy of semaglutide for the treatment of
` type 2 diabetes mellitus in pediatric subjects ages 10 to 17 years
`
`
`
`
` (inclusive). Background therapy will consist of either metformin, insulin, or
`
` metformin plus insulin.
`
`
`
`
`
`Study Completion: December 2026
`
`Final Report Submission: June 2027
`
`
`
`
`
`Submit protocols to your IND 079754, with a cross-reference letter to this NDA.
`
`
`
`
`Reports of this required pediatric postmarketing study must be submitted as an NDA or
`
`
`
`as a supplement to your approved NDA with the proposed labeling changes you believe
`
`are warranted based on the data derived from this study. When submitting the reports,
`
`please clearly mark your submission "SUBMISSION OF REQUIRED PEDIATRIC
`ASSESSMENTS" in large font, bolded type at the beginning of the cover letter of the
`
`
`
`
`submission.
`
`
`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-
`
`
`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
`
`
`
`PATENT LISTING REQUIREMENTS
`
`
`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
`
`
`submitted in a supplement require you to submit patent information for listing in the
`
`
`Orange Book upon approval of the supplement. You must submit the patent information
`
`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
`
`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
`
`
`
`
`
`
` 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
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`
`Reference ID: 4959644
`
`

`

`
`
`
`
`
`
`
` NDA 209637/S-009
`
` Page 4
`
`
` supplement for the patent information to be timely filed (see 21 CFR 314.53(c)(2)(ii)).
`
`
` You also must ensure that any changes to your approved NDA that require the
` submission of a request to remove patent information from the Orange Book are
`
`
`
`
` submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
` 314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
`
`
`
` 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}
`
`
`Patrick Archdeacon, M.D.
`
`
`Associate Director for Therapeutics
`
`
`Division of Diabetes, Lipid Disorders, and Obesity
`
`Office of Cardiology, Hematology, Endocrinology,
`
`and Nephrology
`
`Office of New Drugs
`
`Center for Drug Evaluation and Research
`
`
`
`
`ENCLOSURES:
`
`
`• Content of Labeling
`
`
`o Prescribing Information
`
`
`o Medication Guide
`
`
`
`Instructions for Use (2 mg, 3mL)
`o
`
`
`
`Instructions for Use (0.25 or 0.5 mg, 1.5 mL) (version approved November
`o
`
`27, 2019)
`
`
`
`Instructions for Use (1 mg, 3 mL) (version approved April 9, 2019)
`o
`
`
`
`• Carton and Container Labeling
`
`
`
`
`
` 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: 4959644
`
`

`

`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/
`------------------------------------------------------------
`
`PATRICK ARCHDEACON
`03/28/2022 05:02:13 PM
`
`■
`
`Reference ID: 4959644
`
`(
`
`
`
`