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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-009
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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 November 2, 2007, received
`November 5, 2007, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
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`Sensipar (cinacalcet) Tablets.
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`We acknowledge receipt of your submissions dated April 11 and 21, and May 1, 2008.
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`This supplemental new drug application provides for the addition of information regarding midazolam
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`in the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of the Package Insert (PI).
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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
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`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 and text for patient package insert submitted on May 1, 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-009.”
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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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`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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`NDA 21-688/S-009
`Page 2
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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.
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`/s/
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`Mary Parks
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`5/2/2008 11:45:10 AM
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