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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 21-995/S-007
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`Merck & Co., Inc.
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`Attention: Richard J. Swanson, Ph.D.
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`Director, 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 January 22, 2008, received
`January 22, 2008, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`Januvia (sitagliptin) Tablets.
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`We acknowledge receipt of your submission dated July 21, 2008.
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`This supplemental new drug application provides for the following changes:
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`1. The following statement was added under Warnings and Precautions in the Package Insert (PI):
`“There have been no clinical studies establishing conclusive evidence of macrovascular risk
`reduction with JANUVIA or any other anti-diabetic drug.”
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`2. The following sentence was removed under Clinical Studies in the PI: “JANUVIA has been
`studied as monotherapy and in combination with metformin, pioglitazone, glimepiride, and
`glimepiride+metformin.”
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` 3. The following sentence was removed under What is Januvia? in the Patient Package Insert
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`(PPI): “JANUVIA may be taken alone or along with certain other medicines to control blood
`sugar.”
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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 text and with the
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` following minor editorial revisions: (1) changing the dates in the Highlights section of the PI from
`“XX/20XX” to “7/2008” and (2) revising the date at the end of the PPI from “Month Year” to “July
`2008”.
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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 (text for the
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`package insert, submitted July 21, 2008). Upon receipt, we will transmit that version to the National
`Library of Medicine for public dissemination. For administrative purposes, please designate this
`submission, “SPL for approved NDA 21-995/S-007.”
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`NDA 21-995/S-007
`Page 2
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
`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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` 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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`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: Package Insert, Patient Package Insert
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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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`7/22/2008 09:22:03 AM
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