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`{ ~ lffll U.S. FOOD & DRUG
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`ADMINISTRATION
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` NDA 209637/S-009
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`SUPPLEMENT APPROVAL
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` Novo Nordisk Inc.
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` Attention: Trine Kruse
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` Director, Regulatory Affairs
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` P.O Box 846
` 800 Scudders Mill Road
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` Plainsboro, NJ 08536
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`Dear Ms. Kruse:
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`Please refer to your supplemental new drug application (sNDA) dated and received May
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`28, 2021, and your amendments, submitted under section 505(b) of the Federal Food,
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`Drug, and Cosmetic Act (FDCA) for Ozempic (semaglutide) injection.
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`This Prior Approval sNDA provides for addition of a 3rd maintenance dose of Ozempic (2
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`mg subcutaneously once weekly) (2.68 mg/ml concentration).
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`APPROVAL & LABELING
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`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
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`labeling.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
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`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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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, Instructions for Use, and Medication Guide), with the addition of
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`any labeling changes in pending “Changes Being Effected” (CBE) supplements, as well
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`as annual reportable changes not included in the enclosed labeling.
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4959644
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`Novo Nordisk Exhibit 2107
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
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` NDA 209637/S-009
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` Page 2
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that include labeling
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
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`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
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`Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
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`CARTON AND CONTAINER LABELING
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`Submit final printed carton and container labeling that are identical to the enclosed
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`carton and container labeling as soon as they are available, but no more than 30 days
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`after they are printed. Please submit these labeling electronically according to the
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`guidance for industry Providing Regulatory Submissions in Electronic Format — Certain
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`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
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`Specifications. For administrative purposes, designate this submission “Final Printed
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`Carton and Container Labeling for approved NDA 209637/S-009.” Approval of this
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`submission by FDA is not required before the labeling is used.
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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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`We are waiving the pediatric study requirement for ages 0 through 9 years (inclusive)
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`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.
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`We are deferring submission of your pediatric study for ages 10 to 17 years (inclusive)
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`for this application because this product is ready for approval for use in adults and the
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`pediatric study has not been completed.
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`Your deferred pediatric study required by section 505B(a) of the FDCA is a required
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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
`www.fda.gov
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`Reference ID: 4959644
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`Novo Nordisk Exhibit 2107
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
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` NDA 209637/S-009
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` Page 3
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`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
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`study is listed below.
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`4246-1 Conduct a 52-week, randomized, double-blind, placebo-controlled parallel
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`group study of the safety and efficacy of semaglutide for the treatment of
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`type 2 diabetes mellitus in pediatric subjects ages 10 to 17 years
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`(inclusive). Background therapy will consist of either metformin, insulin, or
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`metformin plus insulin.
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`Study Completion: December 2026
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`Final Report Submission: June 2027
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`Submit protocols to your IND 079754, with a cross-reference letter to this NDA.
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`Reports of this required pediatric postmarketing study must be submitted as an NDA or
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`as a supplement to your approved NDA with the proposed labeling changes you believe
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`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
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`submission.
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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. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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`PATENT LISTING REQUIREMENTS
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`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
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`submitted in a supplement require you to submit patent information for listing in the
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`Orange Book upon approval of the supplement. You must submit the patent information
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`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
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`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
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` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
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`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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`U.S. Food and Drug Administration
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`
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4959644
`
`Novo Nordisk Exhibit 2107
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
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` NDA 209637/S-009
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` Page 4
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`supplement for the patent information to be timely filed (see 21 CFR 314.53(c)(2)(ii)).
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`You also must ensure that any changes to your approved NDA that require the
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`submission of a request to remove patent information from the Orange Book are
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`submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
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`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
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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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`Your product is a Part 3 combination product (21 CFR 3.2(e)); therefore, you must also
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`comply with postmarketing safety reporting requirements for an approved combination
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`product (21 CFR 4, Subpart B). Additional information on combination product
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`postmarketing safety reporting is available at FDA.gov.6
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`If you have any questions, call Lindsey Kelly, Regulatory Project Manager, at
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`301-837-7654.
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`Sincerely,
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`{See appended electronic signature page}
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`
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`Patrick Archdeacon, M.D.
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`Associate Director for Therapeutics
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`Division of Diabetes, Lipid Disorders, and Obesity
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`Office of Cardiology, Hematology, Endocrinology,
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`and Nephrology
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`Office of New Drugs
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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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`Instructions for Use (2 mg, 3mL)
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`o
`Instructions for Use (0.25 or 0.5 mg, 1.5 mL) (version approved November
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`o
`27, 2019)
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`Instructions for Use (1 mg, 3 mL) (version approved April 9, 2019)
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`o
`• Carton and Container Labeling
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` 6 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
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` combination-products
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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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`
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`Reference ID: 4959644
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`Novo Nordisk Exhibit 2107
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
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`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
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`■
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`Reference ID: 4959644
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`(
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`Novo Nordisk Exhibit 2107
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
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