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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 21-688/S-011
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`Amgen Inc.
`Attention: Shi-Ru Anderson
`Manager, Regulatory Affairs
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
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`Dear Ms. Anderson:
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`Please refer to your supplemental new drug application dated May 28, 2008, received May 29, 2008,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Sensipar (cinacalcet
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`HCl) Tablets.
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`We acknowledge receipt of your submissions dated July 24, December 12, and 17, 2008.
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`This supplemental new drug application provides for the following changes to the package insert: (1)
`the addition of arrhythmia to the WARNINGS and ADVERSE REACTIONS sections, and (2) the
`addition of metoprolol and carvedilol as examples of drugs that are predominantly metabolized by
`CYP2D6 to the PRECAUTIONS section.
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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.
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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
`http://www.fda.gov/oc/datacouncil/spl.html that is identical in content to the enclosed labeling (text for
`package insert submitted on DecemerbDecember 17, 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 21-688/S-011.”
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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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`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 21-688/S-011
`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
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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.
`---------------------------------------------------------------------------------------------------------------------
`/s/
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`Mary Parks
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`12/19/2008 03:49:21 PM
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