`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`NDA 22511/S-012
`
`
`
`
`
`
`
`Food and Drug Administration
`
`Silver Spring MD 20993
`
`
`SUPPLEMENT APPROVAL
`
`
`Horizon Pharma USA, Inc.
`Attention: Timothy P. Walbert
`Chairman, President and Chief Executive Officer
`520 Lake Cook Road, Suite 520
`Deerfield, IL 60015
`
`
`Dear Mr. Walbert:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received November
`8, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for Vimovo (naproxen/esomeprazole magnesium) Delayed-Release Tablets.
`
`We acknowledge receipt of your amendment dated February 25, 2014.
`
`We also refer to our letter dated October 10, 2013, notifying you, under Section 505(o)(4) of the
`FDCA, of new safety information that we believe should be included in the labeling for Vimovo.
`This information pertains to the risk of fetal harm in pregnancy, with the use of esomeprazole.
`
`This supplemental new drug application provides for revisions to the labeling for Vimovo. The
`agreed upon changes to the language included in our October 10, 2013, letter are noted in the
`attached label. The following sections were impacted by the labeling revisions in the package
`insert:
`
`HIGHLIGHTS OF PRESCRIBING INFORMATION
`
`• USE IN SPECIFIC POPULATIONS
`FULL PRESCRIBING INFORMATION: CONTENTS
`FULL PRESCRIBING INFORAMTION
`8.
`USE IN SPECIFIC POPULATION
`8.1
`Pregnancy
`
`8.4
`Pediatric use
`NONCLINICAL TOXICOLOGY
`13.2 Animal Toxicology and/or Pharmacology
`
`13
`
`
`
`
`
`
`
`
`Reference ID: 3460368
`
`
`
`
`
` NDA 22511/S-012
`
`Page 2
`
`
` 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.
`
`WAIVER OF HIGHLIGHTS SECTION
`
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of prescribing information.
`
`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 (text for the package insert, Medication
`Guide), 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 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).
`
`
`
`
`
`Reference ID: 3460368
`
`
`
` NDA 22511/S-012
`
`Page 3
`
`
`If you have any questions, call CDR Stacy Barley, Senior Regulatory Project Manager, at (301)
`796-2137.
`
`
`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
`
`
`
`ENCLOSURE(S):
`Content of Labeling
`
`
`Reference ID: 3460368
`
`
`
`---------------------------------------------------------------------------------------------------------
`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
`02/25/2014
`
`Reference ID: 3460368
`
`