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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.
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` Attention: Robert B. Clark
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` VP Regulatory Affairs
` 800 Scudders Mill Road, P.O. Box 846
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` Plainsboro, NJ 08536
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`Dear Mr. Clark:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received
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`August 15, 2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
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`(FDCA) for Victoza (liraglutide [rDNA origin]) injection).
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`We acknowledge receipt of your amendments dated November 10, 2014, and January 12, 2015.
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`We also refer to our letter dated July 17, 2014, notifying you, under Section 505(o)(4) of the
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`FDCA, of new safety information that we believe should be included in the labeling for products
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`indicated for diabetes mellitus that have multi-dose pen presentations. This information pertains
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`to the risk of transmission of bloodborne pathogens resulting from pen devices and pen
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`cartridges that are intended for single patient use only, being shared among numerous patients.
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`This supplemental new drug application provides for revisions to the labeling for Victoza
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`consistent with our July 17, 2014, letter.
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`In our July 17, 2014, letter, we also required you to submit a plan for how you would modify the
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`pen device to include a statement warning against the sharing of pens, on the body of the pen. In
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`your submission dated August 15, 2014, you provided a rationale for why you believe that
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`adding the warning statement to the body of the pen is not necessary and/or feasible. We have
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`reviewed this rationale and found it acceptable that the warning not be placed on the body of the
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`pen at this time.
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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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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022341/S-022
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`Reference ID: 3706643
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` NDA 022341/S-022
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` Page 2
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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 package insert, Medication
`Guide and Instructions for Use), with the addition of any labeling changes in pending “Changes
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`Being Effected” (CBE) supplements, as well as annual reportable changes not included in the
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`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
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`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 includes 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 MS Word format, that includes the
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`changes approved in this supplemental application, as well as annual reportable changes and
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`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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`should provide appropriate annotations, including supplement number(s) and annual report
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`date(s).
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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
`(3) the package insert(s) to:
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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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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
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`Reference ID: 3706643
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`Sincerely,
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`{See appended electronic signature page}
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`Jennifer Rodriguez Pippins, M.D., M.P.H.
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`Deputy Director for Safety
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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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` NDA 022341/S-022
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` Page 3
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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
` Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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` All promotional materials that include representations about your drug product must be promptly
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` 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
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` should include prominent disclosure of the important new safety information that appears in the
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` revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
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` to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
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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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`If you have any questions, call Marisa Petruccelli, Regulatory Project Manager, at
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`(240) 402-6147.
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`ENCLOSURES:
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`Victoza Package Insert
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`Victoza Medication Guide
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`Victoza Instructions for Use
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`Victoza Carton and Container labels
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`Reference ID: 3706643
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`JENNIFER R PIPPINS
`02/25/2015
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`Reference ID: 3706643
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