`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
` NDA 022341/S-023
`
`
`
`
`
`
`
`
`Food and Drug Administration
`
`
` Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`
`
`
`
` Novo Nordisk, Inc.
`
` Attention: Robert B. Clark
`
` VP Regulatory Affairs
` 800 Scudders Mill Road, P.O. Box 846
`
`
` Plainsboro, NJ 08536
`
`
`
`
`Dear Mr. Clark:
`
`
`
`
`
`
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`
`
`November 5, 2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`
`(FDCA) for Victoza (liraglutide [rDNA origin]) injection).
`
`
`
`
`
`
`We acknowledge receipt of your amendments dated December 18, 2014, and January 23,
`
`February 16 and March 3, 2015.
`
`
`
`
`We also refer to our letter dated October 7, 2014, notifying you, under Section 505(o)(4) of the
`
`
`FDCA, of new safety information that we believe should be included in the labeling for long-
`
`
`
`acting GLP-1 receptor agonist products. This information pertains to the risk of medullary
`
`thyroid carcinoma.
`
`
`
`
`
`This supplemental new drug application provides for revisions to the labeling for Victoza
`
`
`
`consistent with our October 7, 2014, letter.
`
`
`APPROVAL & LABELING
`
`We have completed our review of this supplemental application, as amended. It is approved,
`
`
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`
`
`text.
`
`
`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
`
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`
`
`of labeling must be identical to the enclosed labeling (text for the package insert, Medication
`
`Guide and Instructions for Use), with the addition of any labeling changes in pending “Changes
`
`
`
`
`
`
`Reference ID: 3712555
`
`
`
`
`
`
`
`
`
` NDA 022341/S-023
`
` Page 2
`
`
` 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 titled
`
`
`
`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`
` CM072392.pdf
`
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`
`
`Also within 14 days, amend all pending supplemental applications that includes 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 MS Word format, that includes the
`
`changes approved in this supplemental application, as well as annual reportable changes and
`
`
`annotate each change. To facilitate review of your submission, 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).
`
`
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`
`
`
`
`
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`
`
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`
`(3) the package insert(s) to:
`
`
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Office of Prescription Drug Promotion (OPDP)
`
`5901-B Ammendale Road
`
`Beltsville, MD 20705-1266
`
`
`
`
`You must submit final promotional materials and package insert(s), 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
`
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`
`
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`
`more information about submission of promotional materials to the Office of Prescription Drug
`
`
`
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`
`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 package labeling. Within 7 days of receipt of this letter, submit your statement of intent
`
`
`
`Reference ID: 3712555
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` NDA 022341/S-023
`
` Page 3
`
`
` to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
`
`
`REPORTING REQUIREMENTS
`
`
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`If you have any questions, call Marisa Petruccelli, Regulatory Project Manager, at
`
`(240) 402-6147.
`
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Jennifer Rodriguez Pippins, M.D., M.P.H.
`
`
`Deputy Director for Safety
`
`Division of Metabolism and Endocrinology Products
`
`
`Office of Drug Evaluation II
`
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`ENCLOSURES:
`
`Package Insert
`
`Medication Guide
`
`
`
`
`Instructions for Use (version approved on February 25, 2015)
`
`Reference ID: 3712555
`
`