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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-008
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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 June 6, 2007, received June 7, 2007,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Sensipar (cinacalcet
`HCl) Tablets.
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`We acknowledge receipt of your submissions dated October 29, 2007, and February 14, 2008.
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`This supplemental new drug application provides for revisions to the Clinical Studies, Warnings,
`Precautions, and Adverse Events sections of the package insert.
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`We 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 and text for patient package insert submitted on October 29, 2007). 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 21-688/S-008.”
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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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`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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`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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`NDA 21-688/S-008
`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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`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
`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.
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` /s/
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`Mary Parks
`2/28/2008 02:53:41 PM
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