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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 21-688/S-006
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`Amgen Inc.
`Attention: Shi-Ru Anderson
`Manager, Regulatory Affairs
`One Amgen Center Drive
`Thousand Oaks, CA 91320
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`Dear Ms. Anderson:
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`Please refer to your supplemental new drug application dated June 23, 2006, received June 26, 2006,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Sensipar (cinacalcet)
`Tablets.
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`We acknowledge receipt of your submissions dated January 11, April 3, and October 3, 2007.
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`Your submission of April 3, 2007, constituted a complete response to our December 26, 2006, action
`letter.
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`We also refer to our supplement request letter dated April 24, 2006, in which you were asked to revise
`the DRUG INTERATION subsection of the CLINICAL PHARMACOLOGY section and the
`DRUG INTERACTIONS subsection of the PRECAUTIONS section of the package insert.
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`This supplemental new drug application provides for revisions to the following sections of the package
`insert: the DRUG INTERATION subsection of the CLINICAL PHARMACOLOGY section, the
`DRUG INTERACTIONS subsection of the PRECAUTIONS section, for the addition of a sentence
`in the Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis
`subsection of the DOSAGE and ADMINISTRATION section, which states, “PTH levels should be
`assessed no earlier than 12 hours after dosing with Sensipar,” and for removal of “hydrochloride” and
`“HCl” after “cinacalcet” throughout the package insert.
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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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`Within 21 days of the date of this letter, submit 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. Upon receipt and verification, we will transmit that
`version to the National Library of Medicine for public dissemination.
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`NDA 21-688/S-006
`Page 2
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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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`Enclosure: 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.
`---------------------------------------------------------------------------------------------------------------------
` /s/
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`Mary Parks
`10/4/2007 04:07:30 PM
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