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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 201023/S-015
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
`FULFILLMENT OF POSTMARKETING
`REQUIREMENT
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`sanofi-aventis U.S. LLC
`c/o Sanofi US Services Inc.
`Attention: Sunil Gupta, MD
`Associate Vice President, Global Regulatory Affairs
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`500 Kendall Street, Room 05-175C4
`Cambridge, MA 02142
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`Dear Dr. Gupta:
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`Please refer to your Supplemental New Drug Application (sNDA) dated December 22, 2014,
`received December 22, 2014, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for JEVTANA® (cabazitaxel) Injection.
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`We acknowledge receipt of your amendments dated April 30, June 5, and June 15, 2015.
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`This “Prior Approval” supplemental new drug application proposes to change the hepatic
`impairment section of the label based on the final study report for study POP6792, “Phase 1
`Safety and Pharmacokinetic Study of XRP6258 (cabazitaxel) in Advanced Solid Tumor Patients
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` with Varying Degrees of Hepatic Impairment”. This supplement also provides for
`reorganization of the label to be consistent with the Dosage and Administration guidance, as well
`as additional editorial revisions.
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`APPROVAL & LABELING
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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
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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
`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, text for the
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`patient package insert), with the addition of any labeling changes in pending “Changes Being
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`Reference ID: 3780918
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`NDA 201023/S-015
`Page 2
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`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 titled
`“SPL Standard for Content of Labeling Technical Qs and As at
`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
`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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`FULFILLMENT OF POSTMARKETING REQUIREMENT
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`We have received your submission dated December 22, 2014, containing the final report for the
`following postmarketing requirement listed in the June 17, 2010, approval letter.
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`1649-6
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`Conduct the trial POP6972 to determine the pharmacokinetics and safety of
`cabazitaxel in patients with hepatic impairment.
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`We have reviewed your submission and conclude that the above requirement was fulfilled.
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`We remind you that there are postmarketing requirements listed in the June 17, 2010, approval
`letter that are still open.
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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
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`Reference ID: 3780918
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`NDA 201023/S-015
`Page 3
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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
`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.
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`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.
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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, call Charlene Wheeler, Senior Regulatory Project Manager, at
`(301) 796-1141.
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`Sincerely,
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`{See appended electronic signature page}
`
`
`Amna Ibrahim, M.D.
`Deputy Director
`Division of Oncology Products 1
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 3780918
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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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`AMNA IBRAHIM
`06/18/2015
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`Reference ID: 3780918
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