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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDA 22-044/S-002, S-005, S-006
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`Merck & Co., Inc.
`Attention: Steven A. Aurecchia, M.D.
`Director, Regulatory Affairs
`UG2CD-48, P.O. Box 1000
`North Wales, PA 19454-1099
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`Dear Dr. Aurecchia:
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`Please refer to your supplemental new drug applications dated April 18, 2007, received April 19, 2007
`(S-002); dated August 23, 2007, received August 23, 2007 (S-005); and dated September 19, 2007,
`received September 19, 2007 (S-006), submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act for Janumet (sitagliptin/metformin hydrochloride fixed-dose combination) Tablets.
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`We acknowledge receipt of your submissions dated May 11, 2007, May 16, 2007, October 29, 2007,
`and November 30, 2007, to S-002; September 28, 2007, October 29, 2007, and November 30, 2007 to
`S-005; and October 29, 2007, and November 30, 2007, to S-006.
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`Your submission of October 29, 2007, constituted a complete response to our October 19, 2007, action
`letter for S-002.
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`These supplemental new drug applications provide for:
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`S-002: Additions to the Package Insert (PI) and Patient Package Insert (PPI) to include hypersensitivity
`post-marketing adverse reaction data.
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`S-005: Additions to the PI and PPI to include upper respiratory tract infection post-marketing adverse
`reaction information.
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`S-006: Additions to the PI and PPI to include hypersensitivity as a contraindication.
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`We completed our review of these applications, as amended. These applications are approved,
`effective on the date of this letter, for use as recommended in the agreed-upon labeling text and with
`the following minor editorial revisions: (1) revising the dates in the Highlights section of the PI to
`“1/2008” and (2) revising the date at the end of the PPI to “January 2008”.
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`We waive the requirements of 21 CRF 201.57(d)(8) regarding the length of Highlights of prescribing
`information. This waiver applies to all future supplements containing revised labeling unless we notify
`you otherwise.
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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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`

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`NDA 22-044/S-002, S-005, S-006
`Page 2
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`http://www.fda.gov/oc/datacouncil/spl.html that is identical in content to the enclosed labeling (text for
`package insert and text for patient package insert submitted on November 30, 2007, with minor
`revisions). 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 22-044/S-002, S-005, S-006.”
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`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:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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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
`the following address:
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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.
`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
`1/2/2008 07:07:24 PM
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