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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-009
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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 October 10, 2008, received
`October 10, 2008, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`Janumet (sitaglitpin/metformin fixed dose combination) Tablets.
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`This “Changes Being Effected” supplemental new drug application provides for the addition of
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` hepatic enzyme elevations under the Postmarketing Experience subsection of the Adverse Reactions
`setion of the Package Insert. This supplement was submitted in response to our supplement request
`letter dated August 13, 2008.
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`We completed our review of this application. This application is approved, effective on the date of
`this letter, for use as recommended in the agreed-upon labeling text.
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`As soon as possible, but no later than 14 days from the date of this letter, please submit the content
`of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format as described at
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`http://www.fda.gov/oc/datacouncil/spl.html that is identical to the enclosed labeling (submitted
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`October 10, 2008), with the following change: In the Full Prescribing Information: Contents,
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`under 17 Patient Counseling Information, remove the statement “FDA-Approved Patient
`Labeling”. Upon receipt, we will transmit that version to the National Library of Medicine for
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`public dissemination. For administrative purposes, please designate this submission, “SPL for
`approved NDA 22-044/S-009.”
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear
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`Health Care Professional” letter), we request that you submit a copy of the letter to this NDA and a
`copy to the following address:
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`MEDWATCH
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`Food and Drug Administration
`Suite 12B05
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`5600 Fishers Lane
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`Rockville, MD 20857
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`NDA 22-044/S-009
`Page 2
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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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`Enclosure: Package Insert, Patient Package Insert
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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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`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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`10/20/2008 10:24:38 AM
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