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`U.S. FOOD & DRUG
`ADMIN I STRATION
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` NDA 215859
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` CORRECTED NDA APPROVAL
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`Janssen Pharmaceuticals, Inc.
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`Attention: Jennifer Lee
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`Associate Director, Global Regulatory Affairs
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`1125 Trenton-Harbourton Road
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`Titusville, NJ 08560
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`Dear Ms. Lee:
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`Please refer to your new drug application (NDA) dated and received June 22, 2021, and
`your amendments, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Xarelto (rivaroxaban) for oral suspension.
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`We also refer to our approval letter dated December 20, 2021, which contained the
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`following error: The diagram for Figure 6 is missing in the Prescribing Information.
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`This corrected action letter incorporates the correction of the error. The effective action
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`date will remain December 20, 2021, the date of the original letter.
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`This NDA provides for the use of Xarelto (rivaroxaban) for oral suspension for treatment
`of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in
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`pediatric patients from birth to less than 18 years and for thromboprophylaxis in
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`pediatric patients 2 years and older with congenital heart disease after the Fontan
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`procedure.
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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
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`labeling.
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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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`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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`Reference ID: 4909093
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`

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` NDA 215859
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`Page 2
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` the FDA automated drug registration and listing system (eLIST), as described at
` FDA.gov.1 Content of labeling must be identical to the enclosed labeling (Prescribing
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`Information, Instructions for Use, and Medication Guide) as well as annual reportable
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`changes not included in the enclosed labeling. Information on submitting SPL files using
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`eLIST may be found in the guidance for industry SPL Standard for Content of Labeling
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`Technical Qs and As.2
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`The SPL will be accessible via publicly available labeling repositories.
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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
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`carton and container labeling, as soon as they are available, but no more than 30 days
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`after they are printed. Please submit these labeling electronically according to the
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`guidance for industry Providing Regulatory Submissions in Electronic Format — Certain
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`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications. For administrative purposes, designate this submission “Final Printed
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`Carton and Container Labeling for approved NDA 215859.” Approval of this
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`submission by FDA is not required before the labeling is used.
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`DATING PERIOD
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`Based on the stability data submitted to date, the expiry dating period for Xarelto
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`(rivaroxaban) for oral suspension shall be 30 months from the date of manufacture
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`when stored at 25 °C.
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`ADVISORY COMMITTEE
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`Your application for Xarelto was not referred to an FDA advisory committee because
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`the application did not raise significant public health questions on the role of the drug in
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`the diagnosis, cure, mitigation, treatment, or prevention of a disease.
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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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`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`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
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`www.fda.gov
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`
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`Reference ID: 4909093
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`

`

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` NDA 215859
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`Page 3
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` We note that you have fulfilled the pediatric studies requirement for ages birth to <18
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` years for this application.
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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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`Electronic Format—Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials,
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`and the Prescribing Information, at the time of initial dissemination or publication,
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`accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
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`Information and Instructions for completing the form can be found at FDA.gov.5
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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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`If you have any questions, call Carleveva Thompson, Regulatory Project Manager, at
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`301-796-1403.
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`Sincerely,
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`
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`{See appended electronic signature page}
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`
`
`
`Ann Farrell, MD
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`Director
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`Division of Nonmalignant Hematology
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`Office of Cardiology, Hematology,
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`Endocrinology, and Nephrology
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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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`o Prescribing Information
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`o Medication Guide
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`o Instructions for Use
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`• Carton and Container Labeling
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`3 For the most recent version of a guidance, check the FDA guidance web page at
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`https://www.fda.gov/media/128163/download.
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`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4909093
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`

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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/
`------------------------------------------------------------
`
`ANN T FARRELL
`12/21/2021 04:21:18 PM
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`I
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`Reference ID: 4909093
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`(
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