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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022511/S-001
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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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`AstraZeneca LP
`Attention: Laura Garcia-Davenport
`Regulatory Affairs Director
`AstraZeneca LP
`1800 Concord Pike
`P.O. Box 8355
`Wilmington, DE 19803-8355
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`Dear Ms. Garcia-Davenport:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received June 23,
`2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`VIMOVO® (naproxen/esomeprazole magnesium) Tablets.
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`We acknowledge receipt of your amendments dated April 14, 2011, July 20, 2011, August 15,
`2011, and October 26, 2011.
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`We also refer to our letter dated May 25, 2010, notifying you, under Section 505(o)(4) of the
`FDCA, of new safety information that we believe should be included in the labeling for Proton
`Pump Inhibitors (PPIs). This information pertains to the risk of hip, wrist and spine fractures
`with long term use of PPIs.
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`This supplemental new drug application provides for the following revisions to the labeling for
`VIMOVO:
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`• Update the Warning and Precautions (5) section with bone fracture information
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`• Replace the term “anaphylactoid” with “anaphylactic” throughout the label
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`• Update the Medication Guide, “What are the possible side effects of Vimovo?” to include
`additional bone fracture information
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`• Minor editorial changes
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`Reference ID: 3046631
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`

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` NDA 022511/S-001
`Page 2
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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 and with the minor editorial revisions listed below and indicated in the enclosed label.
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`• Highlights: remove the month from Initial US Approval
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`• Highlights: reformat items listed under “Recent Major Changes”
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`• Highlights: Add “and multiple daily dose” under bullet #11 in the Warnings and
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`Precautions section as agreed
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`• Full Prescribing Information: Add “bone fracture” to Section 6.2 (post marketing
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`experience) as agreed
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`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.
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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 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.
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`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`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 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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`Reference ID: 3046631
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` NDA 022511/S-001
`Page 3
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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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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`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 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 Division of Drug Marketing, Advertising, and Communications
`(DDMAC), 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
`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.
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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 CDR Stacy Barley, Senior Regulatory Project Manager, at
`(301) 796-2137.
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`Sincerely,
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`{See appended electronic signature page}
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`Joyce Korvick, M.D., M.P.H.
`Deputy Director for Safety
`Division of Gastroenterology/Inborn Errors Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`ENCLOSURE(S): Content of Labeling
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`Reference ID: 3046631
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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
`11/18/2011
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`Reference ID: 3046631
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