`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`NDA 021688/S-020, 021, 022
`
`
`
`
`
`
`
`
`Food and Drug Administration
`
`
` Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`
`
`Amgen Inc.
`
`Attention: Vanessa Shurn
`
` Senior Manager, Regulatory Affairs
`
`
`
` 9201 Corporate Boulevard, Suite 400
`Rockville, MD 20850
`
`
`
`
`
`Dear Ms. Shurn:
`
`
`
`
`
`
`
`
`
`
`Please refer to your Supplemental New Drug Applications (sNDA) dated and received June 24
`
`
`and December 18, 2013 and May 16, 2014, submitted under section 505(b) of the Federal Food,
`
`
`
`Drug, and Cosmetic Act (FDCA) for Sensipar (cinacalcet hydrochloride) 30 mg, 60mg and
`
`90mg tablet.
`
`
`
`
`
`We acknowledge receipt of your amendments dated February 18, March 21, April 4 and October
`
`14, 2014.
`
`
`
`
`
`
`
`These “Prior Approval” supplemental new drug applications provide for
`
`
`
`
`
`• Labeling supplement-020 dated June 24, 2013: proposes the inclusion of additional safety
`
`
`
`
`
`information to the following subsections of WARNINGS AND PRECAUTIONS:
`
`
`
`Hypocalcemia and USE IN SPECIFIC POPULATION: Pediatric Use.
`
`
`
`• Efficacy supplement-021 dated December 18, 2013: proposes to update the labeling with
`
`
`the recently completed study information and to align the primary hyperparathyroidism
`
`
`
`(pHPT) indication statement to the Orphan Drug Designation for pHPT; ADVERSE
`
`REACTIONS, Clinical Trials Experience, Parathyroid Carcinoma and Primary
`
`
`Hyperparathyroidism; Postmarketing Experience with Sensipar.
`
`
`
`
`
`
`• Labeling supplement-022 dated May 16, 2014: proposes revisions to the following
`
`
`
`
`
`subsections of WARNINGS AND PRECAUTIONS: Hypocalcemia and Neoplastic
`
`
`
`Events; ADVERSE REACTIONS: Clinical Trial Experience.
`
`
`
`
`We further refer to an email correspondence dated November 21, 2014 stating that have we no
`
`
`further comments to your email dated November 20, 2014, which contained a response to our
`
`comments on the package insert.
`
`
`
`
`Reference ID: 3662356
`
`

`

`
`
`
`
`
`
`
`
` NDA 021688/S-020, 021, 022
`
` Page 2
`
`
` APPROVAL & LABELING
`
`
`
`
`
`
`We have completed our review of these supplemental applications, as amended. It is approved,
`
`
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`
`text.
`
`
`CONTENT OF LABELING
`
` 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.
`
`
`Information on submitting SPL files using eList may be found in the guidance for industry titled
`
`
`
`“SPL Standard for Content of Labeling Technical Qs and As at
`
`
`
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`
`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`
`
`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).
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`
`
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`
`
`
`administration are required to contain an assessment of the safety and effectiveness of the
`
`
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`
`
`deferred, or inapplicable.
`
`
`Because none of these criteria apply to your application, you are exempt from this requirement.
`
`
`
`Reference ID: 3662356
`
`

`

`
`
`
`
` NDA 021688/S-020, 021, 022
`
` Page 3
`
`
` PROMOTIONAL MATERIALS
`
`
`
`
`
`
`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:
`
`
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Office of Prescription Drug Promotion (OPDP)
`
`5901-B Ammendale Road
`
`Beltsville, MD 20705-1266
`
`
`
`
`You must submit final promotional materials and package insert(s), accompanied by a Form
`
`
`
`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/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`
`
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`
`more information about submission of promotional materials to the Office of Prescription Drug
`
`
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`
`
`All promotional materials that include representations about your drug product must be promptly
`
`
`revised to be consistent with the labeling changes approved in this supplement, including any
`
`
`
`
`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
`
`
`
`
`
`should include prominent disclosure of the important new safety information that appears in the
`
`
`revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
`
`
`to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
`
`
`
`
`
`
`
`REPORTING REQUIREMENTS
`
`
`
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 3662356
`
`

`

`
`
` NDA 021688/S-020, 021, 022
`
` Page 4
`
`
`
`
` If you have any questions, call Meghna M. Jairath, Pharm.D., Regulatory Project Manager, at
` (301) 796-4267.
`
`
`
`
`
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Jean-Marc Guettier, M.D.
`
`Director
`
`Division of Metabolism and Endocrinology Products
`
`
`Office of Drug Evaluation II
`
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`ENCLOSURE: Content of Labeling: Package insert
`
`Reference ID: 3662356
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JEAN-MARC P GUETTIER
`11/21/2014
`
`Reference ID: 3662356
`
`