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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 22511/S-015
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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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`Horizon Pharma, Inc.
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`Attention: Jeffrey W. Sherman, MD, FACP
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`CMO & Executive VP Research and Development
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`520 Lake Cook Road, Suite 520
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`Deerfield, IL 60015
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`Dear Dr. Sherman:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`August 29, 2014, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Vimovo (naproxen/esomeprazole magnesium) Delayed-Release
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`Tablets.
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`This “Prior Approval” supplemental new drug application provides for revisions to the
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`commercial bottle and sample carton and bottle labels.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`We acknowledge your March 18, 2015, amendment containing final printed carton and container
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`labels.
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(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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`Reference ID: 3721190
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` NDA 22511/S-015
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` Page 2
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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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`ENCLOSURE: Carton and Container Labeling
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`Reference ID: 3721190
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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
`03/25/2015
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`Reference ID: 3721190
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