CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
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`22-044
`
`APPROVAL LETTER
`
`

`

`'4,
`
`C DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`
`Food and Drug Administration
`Rockville. MD 20857
`
`Public Health Service
`
`war,
`‘
`
`NDA 22-044
`
`Merck & Co., Inc.
`Attention: Steven A. Aurecchia, MD.
`Director, Regulatory Affairs
`P.O. BOX 1000, UGZCD-48
`North Wales, PA 19454-1099
`
`Dear Dr. Aurecchia:
`
`Please refer to your new drug application (NDA) dated May 31, 2006, received
`May 31, 2006, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic ACt for
`Janumet (sitagliptin/metformin hydrochloride) tablets, 50 mg sitagliptin/SOO mg metformin HCl and
`50 mg sitagliptin/ 1000 mg metformin HCl.
`
`We acknowledge receipt of your submissions dated July 24, August 24, and October 19, 2006, and
`January 5, February 5 (2), and March 21 and 30, 2007.
`
`This new drug application provides for the use of Janumet (sitagliptin/metformin hydrochloride)
`tablets as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2
`diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients
`already being treated with the combination of sitagliptin and metformin.
`
`We have completed our review of this application, as amended. It is approved, effective on the date of
`this letter, for use as recommended in the agreed-upon labeling text.
`
`Within 21 days of the date of this letter, submit content of labeling [21 CFR 3 1450(1)] in structured
`product labeling (SPL) format, as described at ht_tp://www.fda.gov/oc/datacouncil/spl.Vhtml, that is
`identical in content to the enclosed labeling. Upon receipt and verification, we will transmit that
`version to the National Library of Medicine for public dissemination.
`
`The final printed labeling (FPL) must be identical to the enclosed labeling (text for package insert and
`text for the patient product informationsubmitted on March 30, 2007, and immediate container and
`carton labels submitted on February 5, 2007). Marketing the product with FPL that is not identical to
`the approved labeling text may render the product misbranded and an approved new drug.
`
`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format — NDA. Alternatively, you may submit 20 paper copies
`of the FPL as soon as it is available but no more than 30 days after it is printed. Individually mount 15
`of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`submission “FPL for approved NDA 22-044.” Approval of this submission by FDA is not required
`before the labeling is used.
`
`

`

`NDA 22-044
`
`Page 2
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`All applications for new active ingredients, new dosage forms, new indications, new routes of
`administration, and new dosing regimens are required to contain an assessment of the safety and
`effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are
`waiving the pediatric study requirement for ages birth to 10 years, inclusive, and deferring pediatric
`studies for ages 11 to 16 years, inclusive, for this application.
`
`Your deferred pediatric study required under section 2 of the Pediatric Research Equity Act (PREA) is
`considered a required postmarketing study commitment. The status of this posTtmarketing study shall
`be reported annually according to 21 CFR 314.81. This commitment is listed below.
`
`1. Deferred pediatric study under PREA for the treatment of type 2 diabetes in pediatric patients ages
`11 to 16, inclusive.
`
`Protocol Submission:
`Study Start:
`Final Report Submission:
`
`.
`
`by December 31, 2008
`by March 31, 2009
`by September 30, 2011
`
`Submit final study reports to this NDA. For administrative purposes, all submissions related to this
`
`pediatric postmarketing study commitment must be clearly designated “Required Pediatric Study
`
`Commitment”
`
`In addition, submit three copies of the introductory promotional materials that you propose to use for
`this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to
`this division and two copies of both the promotional materials and the package insert directly to:
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5'901-B Ammendale Road
`
`Beltsville, MD 20705—1266
`
`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 Lina AlJuburi, Pharrn.D., M.S., Regulatory Project Manager, at
`301-796-1168.
`
`Sincerely,
`
`{See appended electronicsignalure page}
`
`Mary H. Parks, MD.
`Director
`
`Division of Metabolism and Endocrinology Products
`Office of Drug Evaluation 11
`Center for Drug Evaluation and Research
`
`Enclosure: Package Insert, Patient Product Information, Container Labels, Carton Labels
`
`

`

`‘ This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Mary Parks
`3/30/2007 07:00:42 PM
`
`