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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 22511/S-019
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Horizon Pharma Inc.
`Attention: Ms. Julie Potter
`Manager, Regulatory Affairs
`150 South Saunders Road
`Lake Forest, IL 60045
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`Dear Ms. Potter:
`
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`Please refer to your Supplemental New Drug Application (sNDA) dated June 7, 2016, received
`June 7, 2016, and your amendments, submitted pursuant to section 505(b)(2) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for Vimovo (naproxen and esomeprazole magnesium)
`delayed-release tablets: 375 mg naproxen/20 mg esomeprazole and 500 mg naproxen/20 mg
`esomeprazole.
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`We acknowledge receipt of your major amendment dated March 31, 2017, which extended the
`goal date by three months.
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`This Prior Approval supplemental new drug application provides for the use of Vimovo
`(naproxen and esomeprazole magnesium) delayed-release tablets: 375 mg naproxen/20 mg
`esomeprazole and 500 mg naproxen/20 mg esomeprazole in adult and adolescent patients 12
`years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of
`arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated
`gastric ulcers.
`The naproxen component of VIMOVO is indicated for relief of signs and symptoms of:
`• osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.
`juvenile idiopathic arthritis (JIA) in adolescent patients.
`•
`The esomeprazole magnesium component of VIMOVO is indicated to decrease the risk of
`developing naproxen-associated gastric ulcers.
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`APPROVAL & LABELING
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`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.
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`Reference ID: 4120692
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`

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`NDA 22511/S-019
`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
`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), 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.
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`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.
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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
`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).
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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
`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.
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`We note that you have fulfilled the pediatric studies requirement for all relevant pediatric age
`groups for this application.
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`PROMOTIONAL MATERIALS
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`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:
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`Reference ID: 4120692
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`

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`NDA 22511/S-019
`Page 3
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`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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`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.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call CAPT Mimi Phan, Regulatory Project Manager, at (301) 796-
`5408.
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`Sincerely,
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`{See appended electronic signature page}
`
`Joyce Korvick, MD, MPH
`Deputy Director for Safety
`Division of Gastroenterology and Inborn Errors
`Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`ENCLOSURES:
`Content of Labeling
`Medication Guide
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`Reference ID: 4120692
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`

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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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`JOYCE A KORVICK
`07/06/2017
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`Reference ID: 4120692
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`