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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 021688/S-020, 021, 022
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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.
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`Attention: Vanessa Shurn
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` Senior Manager, Regulatory Affairs
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` 9201 Corporate Boulevard, Suite 400
`Rockville, MD 20850
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`Dear Ms. Shurn:
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`Please refer to your Supplemental New Drug Applications (sNDA) dated and received June 24
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`and December 18, 2013 and May 16, 2014, submitted under section 505(b) of the Federal Food,
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`Drug, and Cosmetic Act (FDCA) for Sensipar (cinacalcet hydrochloride) 30 mg, 60mg and
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`90mg tablet.
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`We acknowledge receipt of your amendments dated February 18, March 21, April 4 and October
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`14, 2014.
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`These “Prior Approval” supplemental new drug applications provide for
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`• Labeling supplement-020 dated June 24, 2013: proposes the inclusion of additional safety
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`information to the following subsections of WARNINGS AND PRECAUTIONS:
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`Hypocalcemia and USE IN SPECIFIC POPULATION: Pediatric Use.
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`• Efficacy supplement-021 dated December 18, 2013: proposes to update the labeling with
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`the recently completed study information and to align the primary hyperparathyroidism
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`(pHPT) indication statement to the Orphan Drug Designation for pHPT; ADVERSE
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`REACTIONS, Clinical Trials Experience, Parathyroid Carcinoma and Primary
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`Hyperparathyroidism; Postmarketing Experience with Sensipar.
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`• Labeling supplement-022 dated May 16, 2014: proposes revisions to the following
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`subsections of WARNINGS AND PRECAUTIONS: Hypocalcemia and Neoplastic
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`Events; ADVERSE REACTIONS: Clinical Trial Experience.
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`We further refer to an email correspondence dated November 21, 2014 stating that have we no
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`further comments to your email dated November 20, 2014, which contained a response to our
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`comments on the package insert.
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`Reference ID: 3662356
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` NDA 021688/S-020, 021, 022
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` Page 2
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` APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`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
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` 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
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` http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the package insert) with the
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`addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
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`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 titled
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`“SPL Standard for Content of Labeling Technical Qs and As at
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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 that includes labeling changes
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`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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`changes approved in this supplemental application, as well as annual reportable changes and
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`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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`should provide appropriate annotations, including supplement number(s) and annual report
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`date(s).
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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`Reference ID: 3662356
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` NDA 021688/S-020, 021, 022
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` Page 3
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` PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`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
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` (3) the package insert(s) to:
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion (OPDP)
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`5901-B Ammendale Road
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`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
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`FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`All promotional materials that include representations about your drug product must be promptly
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`revised to be consistent with the labeling changes approved in this supplement, including any
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`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
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`should include prominent disclosure of the important new safety information that appears in the
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`revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
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`to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`Reference ID: 3662356
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` NDA 021688/S-020, 021, 022
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` Page 4
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` If you have any questions, call Meghna M. Jairath, Pharm.D., Regulatory Project Manager, at
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`Sincerely,
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`{See appended electronic signature page}
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`Jean-Marc Guettier, M.D.
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`Director
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`Division of Metabolism and Endocrinology Products
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`Office of Drug Evaluation II
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`Center for Drug Evaluation and Research
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`ENCLOSURE: Content of Labeling: Package insert
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`Reference ID: 3662356
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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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`JEAN-MARC P GUETTIER
`11/21/2014
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`Reference ID: 3662356
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