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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 22511/S-006
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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
`Director, Regulatory Affairs
`1800 Concord Pike PO Box 8355
`Wilmington, DE 19803-8355
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`Dear Ms. Firor:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received July 28,
`2011, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Vimovo (naproxen/esomeprazole magnesium) Delayed-ReleaseTablets.
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`We acknowledge receipt of your amendments dated December 1, 2011 and January 12, 2012.
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`This Prior Approval supplemental new drug application provides for the following:
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` Addition of microscopic colitis to post-marketing experience
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` Addition of erlotinib to Drug Interactions section
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` Addition of concomitant use of methotrexate with Proton Pump Inhibitors to the
`Warnings and Precautions and Drug Interactions section
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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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`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 the patient
`package insert), 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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`Reference ID: 3074336
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` NDA 22511/S-006
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`Page 2
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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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`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 Stacy Barley, Regulatory Project Manager, at (301) 796-2137.
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 3074336
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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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`---------------------------------------------------------------------------------------------------------
`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
`01/20/2012
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`Reference ID: 3074336
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