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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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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 202343/S-006
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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. Summneytown Pike
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`P. O. Box 1000, UG2C-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 August 16,
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` 2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
` Juvisync (sitagliptin and simvastatin) Tablets, 100 mg/ 10 mg, 100 mg/ 20 mg, and 100 mg/ 40
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` mg.
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` We acknowledge receipt of your amendment dated December 3, 2012.
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` This “Prior Approval” supplemental new drug application provides for revisions to the package
` insert and Medication Guide to revise instructions that Juvisync should be swallowed whole.
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` This sNDA also provides for revisions to the carton and container labeling to remove instructions
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` to take tablets whole and not to split, crush or chew the tablets.
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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 and Medication
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`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
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`“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
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`Reference ID: 3259088
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` NDA 202343/ S-006
` Page 2
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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 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
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`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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`CARTON AND IMMEDIATE CONTAINER LABELS
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`We acknowledge your December 3, 2012, submission containing final printed carton and
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`container labels.
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`Please submit these labels electronically according to the guidance for industry titled “Providing
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`Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications
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`and Related Submissions Using the eCTD Specifications (June 2008).” Alternatively, you may
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`submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or
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`similar material. For administrative purposes, designate this submission “Product
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`Correspondence – Final Printed Carton and Container Labels for approved NDA
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`202343/S-006.” Approval of this submission by FDA is not required before the labeling is used.
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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 (301) 796­
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`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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`Package Insert
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`Medication Guide
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`Carton and Container Labeling
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`Reference ID: 3259088
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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
`02/11/2013
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`Reference ID: 3259088
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