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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021688/S-025
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`NDA 021688/S-026
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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: Juliana Sholter, MS
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` RAC, Manager, Regulatory Affairs
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` 60113th Street NW, Suite 1100 North
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` Washington, DC 20005
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` Dear Ms. Sholter:
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` Please refer to your Supplemental New Drug Application (sNDA) dated and received September
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` 25, 2018 for NDA 021688/S-025 and September 27, 2018 for NDA 021688/S-026, and your
` amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
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` (FDCA) for Sensipar (cinacalcet) tablets.
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` Supplement-025 provides to revise the presentation of Sensipar’s established name Sensipar
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` (cinacalcet HCl) tablets to Sensipar (cinacalcet) tablets on the container labels and carton
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` labeling to align with the currently approved prescribing information (PI) and to include the
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` strength equivalency statement on the side panel of the container labels, per the Guidance for
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` Industry: Naming of Drug Products Containing Salt Drug Substance.
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` Supplement-026 provides to update the prescribing information to include language regarding
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` switching patients from Parsabiv (etelcalcetide) to Sensipar.
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` APPROVAL & LABELING
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`We have completed our review of this supplemental application, 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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`Reference ID: 4411701
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` NDA 021688/S-025
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` NDA 021688/S-026
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` Page 2
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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 Prescribing Information), with
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`the addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements,
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`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 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 include 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 Microsoft Word format, that includes the
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`changes approved in this supplemental application, as well as annual reportable changes. To
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`facilitate review of your submission(s), provide a highlighted or marked-up copy that shows all
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`changes, as well as a clean Microsoft Word version. The marked-up copy should provide
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`appropriate annotations, including supplement number(s) and annual report date(s).
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`CARTON AND CONTAINER LABELING
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`Submit final printed carton and container labeling that are identical to the enclosed carton and
`container labeling as soon as they are available, but no more than 30 days after they are printed.
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`Please submit these labeling electronically according to the guidance for industry titled
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`Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical
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`Product Applications and Related Submissions Using the eCTD Specifications (April 2018,
`Revision 5). For administrative purposes, designate this submission “Final Printed Carton and
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`Container Labeling for approved NDA 021688/S-025.” Approval of this submission by FDA
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`is not required before the labeling is used.
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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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`Reference ID: 4411701
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` NDA 021688/S-025
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` NDA 021688/S-026
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` Page 3
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` Because none of these criteria apply to your application, you are exempt from this requirement.
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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 Prescribing Information to:
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`OPDP Regulatory Project Manager
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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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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
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`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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`You must submit final promotional materials and Prescribing Information, accompanied by a
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`Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)].
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`Form FDA 2253 is available at
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`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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` 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: 4411701
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` NDA 021688/S-025
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` NDA 021688/S-026
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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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` (301) 796-4267.
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`Sincerely,
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`{See appended electronic signature page}
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`William Chong, M.D.
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`Deputy Director (Acting)
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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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`ENCLOSURES:
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`Content of Labeling
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`Prescribing Information
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`Carton and Container Labeling
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`Reference ID: 4411701
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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
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`WILLIAM H CHONG
`03/29/2019 02:29:13 PM
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`Reference ID: 4411701
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