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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 22-511/S-002 & S-003
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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
`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 Applications (sNDAs) dated and received
`September 23, 2010 (S-002) and September 24, 2010 (S-003), submitted pursuant to section
`505(b)(2) 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 March 24, 2011, May 5, 2011,
`May 23, 2011, and June 6, 2011.
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`These “Prior Approval” supplemental new drug applications provide for the following changes
`to the Medication Guide and listed sections of the package insert:
`• Update the Warning and Precautions (5) section with information regarding severe
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`hepatic impairment, interactions with diagnostic investigations for neuroendocrine
`tumors, and concomitant use with St. John’s Wort or rifampin
`• Update the Drug Interactions (7) section with information regarding interactions with
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`diagnostic investigations for neuroendocrine tumors, and concomitant use with
`cyclosporine, tacrolimus, anticoagulants, digoxin, and St. John’s Wort or rifampin
`• Update the Special Populations (8) section with information regarding severe hepatic
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`impairment
`• Update the Clinical Pharmacology (12) section with information regarding severe
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`hepatic impairment and interactions with diagnostic investigations for neuroendocrine
`tumors
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`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.
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`Reference ID: 2963650
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` NDA 22-511/S-002 & S-003
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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
`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.
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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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`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 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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`Reference ID: 2963650
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` NDA 22-511/S-002 & S-003
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`Page 3
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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 Heather Buck, Regulatory Project Manager, at (301) 796-1413.
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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 and Inborn Errors Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`ENCLOSURE: Content of Labeling
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`Reference ID: 2963650
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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
`06/21/2011
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`Reference ID: 2963650
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