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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 22511/S-008
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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
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`Attention: Laura E. Garcia-Davenport
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`Director, Regulatory Affairs
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`1800 Concord Pike PO Box 8355
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`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 March 27, 2012,
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`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Vimovo
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`(naproxen/esomeprazole magnesium) Delayed Release Tablets.
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`We acknowledge receipt of your amendments dated August 23, 2012, September 28, 2012 and
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`October 4, 2012.
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`This Prior Approval supplemental new drug application provides for the addition of the interaction
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`between esomeprazole and clopidogrel to both the Warnings and Precautions and Drug Interactions
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`sections of the package insert.
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`We have completed our review of this supplemental application, as amended. It is approved, effective on
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`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
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`[21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA automated drug
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`registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of
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`labeling must be identical to the enclosed labeling (text for the package insert and Medication Guide),
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`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
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`files using eLIST may be found in the guidance for industry titled “SPL Standard for Content of Labeling
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`Technical Qs and As” at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM0723
`92.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 these NDAs, including CBE
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`supplements for which FDA has not yet issued an action letter, with the content of labeling
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`[21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes approved in this supplemental
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`Reference ID: 3200888
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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.
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`Deputy Director for Safety
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`Division of Gastroenterology and Inborn Errors Products
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`Office of Drug Evaluation III
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`Center for Drug Evaluation and Research
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` NDA 22511/S-008
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` Page 2
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` 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
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` 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
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` information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials should include
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` prominent disclosure of the important new safety information that appears in the revised package
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` labeling. Within 7 days of receipt of this letter, submit your statement of intent to comply with
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` 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
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`and 314.81).
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`If you have any questions, call Stacy Barley, Senior Regulatory Project Manager, at (301) 796-2137.
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`ENCLOSURE:
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`Content of Labeling
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`Reference ID: 3200888
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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
`10/09/2012
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`Reference ID: 3200888
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