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` DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
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`Food and Drug Administration
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`Rockville, MD 20857
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`NDA 22-044/S-007
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`Merck & Co., Inc.
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`Attention: Richard J. Swanson, Ph.D.
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`Director, Worldwide Regulatory Affairs
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`P.O. Box 1000, UG2C-50
`North Wales, PA 19454-1099
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`Dear Dr. Swanson:
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`Please refer to your supplemental new drug application dated November 2, 2007, received
`Novemebr 2, 2007, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
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`Janumet (sitagliptin/metformin hydrochloride fixed dose combination) Tablets.
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`We acknowledge receipt of your submission dated April 9, 2008.
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`This “Changes Being Effected in 30 days” supplemental new drug application provides for the addition
`of the Manati, Puerto Rico manufacturing site.
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`We have completed our review of this application, as amended. This application is approved, effective
`on the date of this letter, for use as recommended in the agreed-upon labeling to be used at the Manati,
`Puerto Rico manufacturing site.
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`The final printed labeling (FPL) to be used at the Manati, Puerto Rico manufacturing site must be
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`identical to the enclosed labeling (immediate container and carton labels submitted on April 9, 2008).
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`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
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`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 supplement NDA 22-044/S-007.” Approval of this submission by
`FDA is not required before the labeling is used.
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`We remind you of your commitment communicated by email on April 29, 2008, to Teshara Bouie, to
`provide stability data from the first commercial batch which, when available, will be provided in the
`next annual report.
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`We have not completed validation of the regulatory methods. However, we expect your continued
`cooperation to resolve any problems that may be identified.
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
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` Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
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` the following address:
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`NDA 22-044/S-007
`Page 2
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`MEDWATCH
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`Food and Drug Administration
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`Suite 12B05
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`5600 Fishers Lane
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`Rockville, MD 20857
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Julie Marchick, Regulatory Project Manager, at (301) 796-1280.
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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
`Division of Metabolism and Endocrinology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`Enclosures: Carton and Container Labels to be used at the Manati, Puerto Rico manufacturing site
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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.
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`/s/
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`Mary Parks
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`5/1/2008 04:00:43 PM
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