`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`NDA 022341/S-007
`NDA 022341/S-009
`
`NDA 022341/S-013
`
`
`
`
`
`
`
`Food and Drug Administration
`
`Silver Spring MD 20993
`
`
`SUPPLEMENT APPROVAL
`
`
`Novo Nordisk Inc.
`Attention: Anne Phillips, M.D.
`Corporate Vice President, CMR
`100 College Road West
`Princeton, NJ 08540
`
`Dear Dr. Phillips:
`
`
`Please refer to your Supplemental New Drug Applications (sNDAs) submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Victoza (liraglutide [rDNA
`origin] injection).
`
`SUPPLEMENT NUMBER:
`DATE OF SUBMISSION:
`DATE OF RECEIPT:
`
`We acknowledge receipt of your amendments dated:
`
`S-007: September 9, October 21, December 7, 2011, and March 5, April 6, 2012
`S-009: August 2, September 19, 22, 27, October 3, 2011, February 8, 22, and March 2, April 6,
`2012
`S-013: April 6, 2012
`
`These “Prior Approval” supplemental new drug applications provide for the following:
`
`
`S-007
`June 8, 2011
`June 8, 2011
`
`S-009
`June 30, 2011
`June 30, 2011
`
`S-013
`October 6, 2011
`October 6, 2011
`
`
`1) Revisions to the Physician Insert (PI) based on the efficacy and safety results from Study
`NN2211-1860, entitled The Effect of Liraglutide Compared to Sitagliptin, Both in
`Combination with Metformin in Subjects with Type 2 Diabetes. A 26-Week, Randomised,
`Open-label, Active Comparator, Three-Armed, Parallel-Group, Multi-Centre, Multi-
`National Trial With a 52-Week Extension (S-007),
`
`
`
`2) Revisions to the PI based on the efficacy and safety results from Study NN2211-1842,
`entitled The Effect of Insulin Detemir in Combination with Liraglutide and Metformin
`Compared to Liraglutide and Metformin in Subjects with Type 2 Diabetes. A 26-week,
`Randomized, Open-label, Parallel-group, Multicentre, Multinational Trial with a 26-
`week Extension (S-009), and
`
`
`
`
`Reference ID: 3112608
`
`
`
`
` NDA 022341/S-007
`
` NDA 022341/S-009
`
` NDA 022341/S-013
`Page 2
`
`
`
`3) Revisions to the PI and Medication Guide based on postmarketing reports of serious
` hypersensitivity reactions, including anaphylactic reactions and angioedema (S-013).
`
`
`
`We have completed our review of these supplemental applications, as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`
` upon labeling text.
`
`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`prescribing information. This waiver applies to all future supplements containing revised
`
` labeling unless we notify you otherwise.
`
`
`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, 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
`
`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 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).
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, 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(s) 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
`
`
`
`Reference ID: 3112608
`
`
`
`
`
`
` NDA 022341/S-007
`
` NDA 022341/S-009
`
` NDA 022341/S-013
`Page 3
`
`
` 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/opacom/morechoices/fdaforms/cder.html;
`instructions are provided on page 2 of the form. 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
`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).
`
`We request that for a period of two years, you submit an annual summary report in your periodic
`safety update report of all product quality issues (malfunctions and complaints) with the
`autoinjector pen. The summary report should provide details of any modifications or corrective
`actions to or for the device, and also include any trending analysis conducted.
`
`Additionally, we request that for a period of two years, you submit all cases of hemorrhagic
`and/or necrotizing pancreatitis and all cases of suspected or confirmed reports of acute
`pancreatitis with an outcome of death as 15-day alert reports, and that you provide analyses of
`clinical trial and post-marketing reports of pancreatitis, including hemorrhagic and/or necrotizing
`pancreatitis, as adverse events of special interest in your periodic safety update reports.
`
`
`Reference ID: 3112608
`
`
`
`
` NDA 022341/S-007
`
` NDA 022341/S-009
`
` NDA 022341/S-013
`Page 4
`
`If you have any questions, please call Pooja Dharia, Pharm.D., Regulatory Project Manager, at
`(301) 796-5332.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Mary Parks, M.D.
`Director
`
`Division of Metabolism and Endocrinology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`
`ENCLOSURES:
`Package Insert
`Medication Guide
`
`
`Reference ID: 3112608
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`AMY G EGAN
`04/06/2012
`Amy Egan for Mary Parks
`
`Reference ID: 3112608
`
`