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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`NDA 021688/S-013
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`Amgen Inc.
`Attention: Shi-Ru Anderson
`Manager, Regulatory Affairs
`One Amgen Center Drive
`Thousand Oaks, CA 91320
`
`
`Dear Ms. Anderson:
`
`Please refer to your supplemental new drug application dated May 11, 2009, received May 12,
`2009, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Sensipar
`(cinacalcet HCl) Tablets.
`
`This “Prior Approval” supplemental new drug application proposes to add descriptions of the
`hypersensitivity reaction (adding angioedema and urticaria) to the Post-Marketing sub-section of
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`the Adverse Events section of 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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` CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, please re-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 the package insert submitted on May 11, 2009. 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-013.”
`
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`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert
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`to:
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`
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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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` NDA 021688/S-013
`Page 2
`
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert(s), at the time of initial dissemination or publication, accompanied by a Form
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`FDA 2253. For instruction on completing the Form FDA 2253, see page 2 of the Form. For
`more information about submission of promotional materials to the Division of Drug Marketing,
`Advertising, and Communications (DDMAC), see
`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`LETTERS TO HEALTH CARE PROFESSIONALS
`
`
`If you issue a letter communicating important safety related information about this drug product
`(i.e., a “Dear Health Care Professional” letter), we request that you submit an electronic copy of
`the letter to both this NDA and to the following address:
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`
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`MedWatch
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`Food and Drug Administration
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`5600 Fishers Lane, Room 12B05
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`Rockville, MD 20857
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`REPORTING REQUIREMENTS
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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).
`
`
`If you have any questions, please contact Mehreen Hai, Ph.D., Regulatory Project Manager, at
`(301) 796-5073.
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`Sincerely,
`
`
`
`
`
`{See appended electronic signature page}
`
`
`Mary H. Parks, M.D.
`Director
`
`Division of Metabolism & Endocrinology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`Enclosure:
`Package Insert
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`Application
`Type/Number
`--------------------
`NDA-21688
`
`Submission
`Type/Number
`--------------------
`SUPPL-13
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`Submitter Name
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`Product Name
`
`--------------------
`AMGEN INC
`
`------------------------------------------
`SENSIPAR(CINACALCET HCL)
`30/60/90MG TABS
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MARY H PARKS
`11/12/2009
`
`
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