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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021688/S-015
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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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`Amgen Inc.
`Attention: Shi-Ru Anderson
`Senior 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 (sNDA) dated April 26, 2010, received
`April 27, 2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Sensipar (cinacalcet) tablets, 30 mg, 60 mg, 90 mg.
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`We acknowledge receipt of your amendments dated May 24, August 2, and December 1, 2010,
`and February 24, 2011.
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`This “Prior Approval” supplemental new drug application provides for:
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`1. A new indication, “treatment of severe hypercalcemia in patients with primary
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`hyperparathyroidism who are unable to undergo parathyroidectomy.”
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`2. The inclusion of data from an additional 19 subjects with hypercalcemia from parathyroid
`carcinoma to the information currently presented in the label.
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`3. Conversion of the labeling to the Physician Labeling Rule (PLR) format.
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert), with the
`addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
`well as annual reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`titled “SPL Standard for Content of Labeling Technical Qs and As” at
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`Reference ID: 2910153
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`

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` NDA 021688/S-015
`Page 2
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications for this NDA, including CBE
`supplements for which FDA has not yet issued an action letter, with the content of labeling
`[21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes approved in this
`supplemental application, as well as annual reportable changes and annotate each change. To
`facilitate review of your submission, provide a highlighted or marked-up copy that shows all
`changes, as well as a clean Microsoft Word version. The marked-up copy should provide
`appropriate annotations, including supplement number(s) and annual report date(s).
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) 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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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
`FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html;
`instructions are provided on 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.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to 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, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA to the following
`address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
`10903 New Hampshire Ave
`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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`Reference ID: 2910153
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` NDA 021688/S-015
`Page 3
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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).
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`If you have any questions, please call Pooja Dharia, Pharm.D., Regulatory Project Manager, at
`(301) 796-5332.
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`Sincerely,
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` {See appended electronic signature page}
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`Mary Parks, M.D.
`Director
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`Division of Metabolism and Endocrinology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 2910153
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`

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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 H PARKS
`02/25/2011
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`Reference ID: 2910153
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