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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021995/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
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`P. O. Box 1000, UG2CD-48
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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 May 31,
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`2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
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`Januvia (sitagliptin) tablets, 25 mg; 50 mg; 100 mg.
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`We acknowledge receipt of your amendments dated June 6, 2013, and July 3, 2013.
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`This “Prior Approval” supplemental new drug application provides for deletion of text in the
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`Initial Combination Therapy with Metformin subsection of Section 14.1 that describes results
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`from an open-label treatment arm of the study. This revision was made in response to our April
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`26, 2013, letter requesting that such information be removed from the Package Insert. In
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`addition, several minor changes were made to the Medication Guide.
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`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
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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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, text for the
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`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
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`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
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`“SPL Standard for Content of Labeling Technical Qs and As at
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`Reference ID: 3359729
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` NDA 21995/S-029
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` Page 2
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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` 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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`Mary H. Parks, M.D.
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`Director
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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: 3359729
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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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`MARY H PARKS
`08/19/2013
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`Reference ID: 3359729
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