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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21-926/S-006
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
`REMS ELIMINATION
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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 May 28,
`2010 submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Treximet tablets.
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`We acknowledge receipt of your amendments dated July 23, 2010, August 31, 2010, November
`9, 2010, and June 27, 2011, and of your risk evaluation and mitigation strategy (REMS)
`assessments dated November 12, 2009, and April 13, 2011.
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`This supplemental new drug application proposes revisions to the Treximet Medication Guide,
`and to eliminate the requirement for the approved Treximet REMS.
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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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` RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
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`The REMS for Treximet (sumatriptan and naproxen sodium) was originally approved on April
`15, 2008. The REMS consists of a Medication Guide and a timetable for submission of
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`assessments of the REMS.
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`You propose that FDA no longer require a REMS for Treximet (sumatriptan and naproxen
`sodium).
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`We have determined that maintaining the Medication Guide as part of the approved labeling is
`adequate to address the serious and significant public health concern and meets the standard in
`21 CFR 208.1. Therefore, it is no longer necessary to include the Medication Guide as an
`element of the approved REMS to ensure that the benefits of Treximet (sumatriptan and
`naproxen sodium) outweigh its risks.
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`Reference ID: 3017910
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` NDA 21-926/S-006
`Page 2
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`Therefore, we agree with your proposal and a REMS for Treximet (sumatriptan and naproxen
`sodium) is no longer required.
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`We remind you that the Medication Guide will continue to be part of the approved labeling in
`accordance with 21 CFR 208.
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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
`patient 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
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`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 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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`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}
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`Reference ID: 3017910
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` NDA 21-926/S-006
`Page 3
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`ENCLOSURE(S):
`Medication Guide
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`Russell G. 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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`Reference ID: 3017910
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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
`09/23/2011
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`Reference ID: 3017910
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`