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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022044/S-029
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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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`Merck Sharp & Dohme Corp.
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`Attention: Lou Ann Eader, Ph.D
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`Director, Worldwide Regulatory Affairs
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`351 N. Sumneytown Pike, P. O. Box 1000
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`UG 2C-50
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`North Wales, PA 19454-1099
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`Dear Dr. Eader:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`March 26, 2013, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Janumet (sitagliptin and metformin HCl) tablets, 50 mg/ 500 mg and
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`50 mg/ 1000 mg.
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`We acknowledge receipt of your amendment dated August 27, 2013.
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`This “Prior Approval” supplemental new drug application provides for changes to multiple
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`sections of the package insert and Medication Guide to harmonize labeling with the currently
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`approved labeling for Janumet XR (NDA 202270/S-003, approved on February 11, 2013). This
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`sNDA also includes annual reportable changes to the labeling.
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` APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is approved, effective on the
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`date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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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
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`201.57(d)(8) regarding the length of Highlights of prescribing information.
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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
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`Reference ID: 3371408
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` NDA 022044/S-029
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` Page 2
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` automated drug registration and listing system (eLIST), as described at
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` http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`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)
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`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
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf. The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that includes labeling changes
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`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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`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-
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`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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`should provide appropriate annotations, including supplement number(s) and annual report
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`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
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Richard Whitehead, Regulatory Project Manager, at
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`(301) 796-4945.
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`Sincerely,
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`{See appended electronic signature page}
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`Jean-Marc Guettier, M.D.
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`Director (Acting)
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`Division of Metabolism and Endocrinology Products
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`Office of Drug Evaluation II
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`Content of Labeling
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`Package Insert
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`Medication Guide
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`Reference ID: 3371408
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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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`JEAN-MARC P GUETTIER
`09/11/2013
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`Reference ID: 3371408
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