`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`NDA 22511/S-016
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`
`Horizon Pharma, Inc.
`Attention: Jeffrey W. Sherman, MD, FACP
`CMO & Executive Vice President
`Development, Manufacturing, and Regulatory Affairs
`520 Lake Cook Road, Suite 520
`Deerfield, IL 60015
`
`
`Dear Dr. Sherman:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`September 19, 2014, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Vimovo (naproxen/esomeprazole magnesium) Delayed-Release
`Tablets.
`
`We acknowledge receipt of your amendments dated January 2, 2015, April 17, 2015 and
`May 28, 2015.
`
`This “Prior Approval” supplemental new drug application provides for additions to the Warnings
`and Precautions and Adverse Reactions sections of the package insert based on postmarketing
`experience with Vimovo, naproxen and esomeprazole.
`
`APPROVAL & LABELING
`
`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.
`
`CONTENT OF LABELING
`
`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.
`
`
`Reference ID: 3781936
`
`
`
`NDA 22511/S-016
`Page 2
`
`
`Information on submitting SPL files using eList may be found in the guidance for industry titled
`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`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).
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Heather Buck, Regulatory Project Manager, at (301) 796-1413.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`
`
`
`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
`
`
`ENCLOSURES: Content of Labeling
`
`
`Reference ID: 3781936
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JOYCE A KORVICK
`06/19/2015
`
`Reference ID: 3781936
`
`