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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 209637/S-001
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`Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` Novo Nordisk Inc.
` Attention: Mette Stensler-Thomsen
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` 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. Stensler-Thomsen:
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` Please refer to your Supplemental New Drug Application (sNDA) dated and received October 1,
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` 2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
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` Cosmetic Act (FDCA) for Ozempic (semaglutide) injection.
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` This Prior Approval supplemental new drug application provides for a new presentation of the
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` PDS290 pen-injector which incorporates a 3 mL cartridge and is designed to deliver 4 doses of
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` 1 mg semaglutide. This supplement provides for updates to the Prescribing Information, as well
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` as new Instructions for Use, and new carton and container labeling.
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` APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text.
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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 content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the Prescribing Information,
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`Medication Guide, and Instructions for Use), with the addition of any labeling changes in
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`Reference ID: 4416585
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` NDA 209637/S-001
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` Page 2
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` pending “Changes Being Effected” (CBE) supplements, as well as annual reportable changes not
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`included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
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`“SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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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 changes
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` for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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` with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word format, that includes the
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` changes approved in this supplemental application, as well as annual reportable changes. To
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` facilitate review of your submission(s), provide a highlighted or marked-up copy that shows all
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` changes, as well as a clean Microsoft Word version. The marked-up copy should provide
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` 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 carton and
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`container labeling as soon as they are available, but no more than 30 days after they are printed.
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`Please submit these labeling electronically according to the guidance for industry titled
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`Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical
`Product Applications and Related Submissions Using the eCTD Specifications (April 2018,
`Revision 5). For administrative purposes, designate this submission “Final Printed Carton and
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`Container Labeling for approved NDA 209637/S-001” Approval of this submission by FDA
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`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 new
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`active ingredients (which includes new salts and new fixed combinations), new indications, new
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`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
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`patients unless this requirement is waived, deferred, or inapplicable.
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`Because none of these criteria apply to your supplemental application, you are exempt from this
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`requirement.
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`SUPPLEMENT REQUEST
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` The Instructions for Use and carton and container labeling for the two other pen injector variants
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`should be updated for consistency, where appropriate, with the Instructions for Use and carton
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`and container labeling for the new pen injector approved under NDA 209637/S-001. Submit
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`draft revised labeling for your Instructions for Use and carton and container labeling for the other
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`Reference ID: 4416585
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` NDA 209637/S-001
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` Page 3
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` pen variants as a prior approval supplement. To facilitate review of your submission, provide a
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` highlighted or marked-up copy that shows all your proposed changes as well as a clean version
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` of the IFU in Word format and a clean version of carton and container labeling in PDF format.
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` The marked-up copy should also include annotations that support all your proposed changes,
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` including annual reportable changes. Your supplement must include updated content of labeling
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` in structured product labeling (SPL) format, according to 21 CFR 314.50(l)(1)(i) (see
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` http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm).
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`Submit this prior approval supplement within 60 days of the date of this letter.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
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`(3) the Prescribing Information 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 (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
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`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
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`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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`You must submit final promotional materials and Prescribing Information, accompanied by a
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`Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)].
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`Form FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
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` Information and Instructions for completing the form can be found at
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` http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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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`Reference ID: 4416585
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` NDA 209637/S-001
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` Page 4
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` If you have any questions, call Peter Franks, Regulatory Project Manager, at (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 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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`Prescribing Information
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`Medication Guide (version approved December 5, 2017)
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`Instructions for Use (1 mg, 1.5 mL) version approved December 5, 2017
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`Instructions for Use (0.25 or 0.5 mg, 1.5 mL) version approved December 5, 2017
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`Instructions for Use (1 mg, 3 mL)
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`Carton and Container Labeling
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`Reference ID: 4416585
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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.
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`/s/
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`LISA B YANOFF
`04/09/2019 12:39:28 PM
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`Reference ID: 4416585
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`(
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