throbber

`
`
` 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
`
`(
`
`
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket