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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21-926/S-005
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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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`GlaxoSmithKline
`Attention: Elizabeth A. McConnell, Pharm.D.
`Five Moore Drive
`P.O. Box 13398
`Research Triangle Park, NC 27709
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`Dear Dr. McConnell:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received January
`28, 2010, submitted under section 505(b)of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for TREXIMET (sumatriptan and naproxen sodium) tablets.
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`We acknowledge receipt of your amendments dated December 5, 2011, and January 6, 2012.
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`This “Changes Being Effected” supplemental new drug application provides for the addition of
`the following wording to the WARNINGS: Risk of Gastrointestinal Ulceration, Bleeding, and
`Perforation With Nonsteroidal Anti-inflammatory Drug Therapy section of approved labeling:
`“NSAIDs should be given with care to patients with a history of inflammatory bowel disease
`(ulcerative colitis, Crohn's disease) as their condition may be exacerbated”, and for minor
`editorial changes to other sections of 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.
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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 the enclosed labeling (text for the package insert, text for the
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`patient package insert), 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
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`titled “SPL Standard for Content of Labeling Technical Qs and As” at
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`Reference ID: 3088126
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`

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` NDA 21-926/S-005
`Page 2
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.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 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).
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`MARKET PACKAGE
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`Please submit one market package of the drug product when it is available.
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`If sending via USPS, please send to:
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`Lana Chen
`Food and Drug Administration
`Center for Drug Evaluation and Research
`White Oak Building 22, Room: 4353
`10903 New Hampshire Avenue
`Silver Spring, Maryland 20993
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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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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html;
`instructions are provided on page 2 of the form. For more information about submission of
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`If sending via any carrier other than USPS
`(e.g., UPS, DHL), please send to:
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`Lana Chen
`Food and Drug Administration
`Center for Drug Evaluation and Research
`White Oak Building 22, Room: 4353
`10903 New Hampshire Avenue
`Silver Spring, Maryland 20903
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`Reference ID: 3088126
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` NDA 21-926/S-005
`Page 3
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`promotional materials to the Division of Drug Marketing, Advertising, and Communications
`(DDMAC), 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 Lana Chen, Regulatory Project Manager, at (301) 796-1056.
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`Sincerely,
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` {See appended electronic signature page}
`
`Russell Katz, MD
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` Director
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`ENCLOSURE: Content of Labeling
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`Reference ID: 3088126
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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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`RUSSELL G KATZ
`03/01/2012
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`Reference ID: 3088126
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`