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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 205103/S-1
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Aralez Pharmaceuticals Trading DAC
`C/o Mapi USA, Inc
`Attention: Jennifer Sanguedolce, MS., RAC
`Senior Manager, US Regulatory Affairs
`2343 Alexandria Drive
`Lexington, KY 40504
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`Dear Ms. Sanguedolce:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated April 5, 2017, received
`April 5, 2017, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic
`Act (FDCA) for Yosprala delayed-release tablets (aspirin 81 mg/omeprazole 40 mg, and aspirin
`325 mg/omeprazole 40 mg).
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`We also refer to our letter dated March 7, 2017, notifying you of changes made to the label of the
`referenced listed drug, Prilosec (omeprazole magnesium), approved on October 24, 2016, and
`requesting a Prior Approval Supplement for Yosprala. The changes pertain to the risk of serious
`cutaneous and systemic lupus erythematosus events associated with the use of PPIs.
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`This supplemental new drug application provides for revisions to the Warnings and Precautions
`section of the Prescribing Information and the Medication Guide for Yosprala, consistent with
`the approved prescribing Information (PI) and Medication Guide (MG) for Prilosec (omeprazole
`magnesium) dated October 2016.
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`APPROVAL & LABELING
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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 and with the minor editorial revisions indicated in the enclosed labeling.
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`WAIVER OF HIGHLIGHTS SECTION
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`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.
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`Reference ID: 4163016
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`

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`NDA 205103/S-1
`Page 2
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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, except with the revisions indicated, 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.
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`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
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`The SPL will be accessible via 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 with the revisions
`indicated above 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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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
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`Reference ID: 4163016
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`

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`NDA 205103/S-1
`Page 3
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`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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`You must submit final promotional materials and package insert(s), accompanied by a Form
`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
`FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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 CAPT Mimi T. Phan, Regulatory Project Manager, at (301) 796-
`5408.
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`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
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`ENCLOSURES: Content of Labeling -- Prescribing Information and Medication Guide
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`Reference ID: 4163016
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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
`10/04/2017
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`Reference ID: 4163016
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