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` NDA 201023/S-026
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`SUPPLEMENT APPROVAL
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` Sanofi-aventis U.S. LLC
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` c/o Sanofi Company
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` Attention: John Cook
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` Senior Director, Global Regulatory Affairs
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` 55 Corporate Drive
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` Bridgewater, NJ 08807
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`Dear Mr. Cook:
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`Please refer to your supplemental new drug application (sNDA) dated
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`January 27, 2023, received January 27, 2023, and your amendments, submitted under
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`section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Jevtana
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`(cabazitaxel) injection.
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`This Prior Approval sNDA provides for revision of Section 8.3 (Females and Males of
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`Reproductive Potential), Section 17 (Patient Counseling Information) and the Patient
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`Information leaflet to update the information on duration of use of effective contraception
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`to 4 months after the last dose of Jevtana and conservation of sperm prior to treatment
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`and revision ofSection 13.1 (Carcinogenesis, Mutagenesis, Impairment of Fertility) to
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`update information on the mechanism of genotoxicity.
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`APPROVAL & LABELING
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`We have completed our review of this 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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`with minor editorial revisions listed below and reflected in the enclosed labeling.
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`• Patient Package Insert format has a minor change.
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`• Recent Major Changes section has been updated based on the labeling revision.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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` We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of
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` Highlights of Prescribing Information. This waiver applies to all future supplements
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` containing revised labeling unless we notify you otherwise.
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`Reference ID: 5203750
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` NDA 201023/S-026
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` Page 2
` 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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (Prescribing
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`Information and Patient Package Insert), with the addition of any labeling changes in
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`pending “Changes Being Effected” (CBE) supplements, as well as annual reportable
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`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
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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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
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
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`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
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`supplement number(s) and annual report 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
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 5203750
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` NDA 201023/S-026
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` Page 3
` Electronic Format-Promotional Labeling and Advertising Materials for Human
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` Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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`All promotional materials that include representations about your drug product must be
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`promptly revised to be consistent with the labeling changes approved in this
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`supplement, including any new safety- related information [21 CFR 314.70(a)(4)]. The
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`revisions in your promotional materials should include prominent disclosure of the
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`important new safety-related information that appears in the revised labeling. Within 7
`days of receipt of this letter, submit your statement of intent to comply with
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`21 CFR 314.70(a)(4).
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`PATENT LISTING REQUIREMENTS
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`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
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`submitted in a supplement require you to submit patent information for listing in the
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`Orange Book upon approval of the supplement. You must submit the patent information
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`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
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`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
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`supplement for the patent information to be timely filed (see 21 CFR
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`314.53(c)(2)(ii)). You also must ensure that any changes to your approved NDA that
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`require the submission of a request to remove patent information from the Orange Book
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`are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
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`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
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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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` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
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`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 5203750
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` NDA 201023/S-026
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` Page 4
` If you have any questions, contact Sso (Anna) Lee, Regulatory Project Manager, at
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` (301) 796-0282 or at Sso.Lee@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`
`Sundeep Agrawal, MD
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`Supervisory Associate Director (Acting)
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`Division of Oncology 1
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`Office of Oncologic Diseases
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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`o Patient Package Insert
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` U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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` www.fda.gov
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`Reference ID: 5203750
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`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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`SUNDEEP AGRAWAL
`07/07/2023 11:46:10 AM
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`Reference ID: 5203750
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