`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
` NDA 022044/S-027
`
`
`
`
`
`
`
`
`
`Food and Drug Administration
`
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`Merck Sharp & Dohme Corp.
`Attention: Lou Ann Eader, Ph.D.
`Director, Worldwide Regulatory Affairs
`351 N. Summneytown Pike
`P. O. Box 1000, UG2C-50
`North Wales, PA 19454-1099
`
`
`Dear Dr. Eader:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received August 16,
`2012, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Janumet (sitagliptin and metformin HCl) Tablets, 50 mg/500 mg, and 50 mg/1000
`mg.
`
`We acknowledge receipt of your amendment dated December 3, 2012.
`
`This “Prior Approval” supplemental new drug application provides for revisions to the package
`insert and Medication Guide to add instructions to take tablets whole and not to split, crush, or
`chew the tablets.
`
`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.
`
`
`CONTENT OF LABELING
`
`
`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 and 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.
`
`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
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`
`Reference ID: 3257800
`
`

`

`NDA 022044/S-027
`Page 2
`
`
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`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).
`
` REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Richard Whitehead, Regulatory Project Manager, at (301) 796-
`4945.
`
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Mary H. Parks, M.D.
`Director
`
`Division of Metabolism and Endocrinology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`ENCLOSURES:
`Package Insert
`Medication Guide
`
`
`Reference ID: 3257800
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MARY H PARKS
`02/07/2013
`
`Reference ID: 3257800
`
`