`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
` NDA 022406/S-012
`
`
`
`
`
`
`
`
`
`Food and Drug Administration
`
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`
`
` Janssen Pharmaceuticals, Inc.
`
` c/o Janssen Research & Development, LLC
`Attention: Huy Q. Truong, MS
`Associate Director, Global Regulatory Affairs
`920 U.S. Highway 202, P.O. Box 300
`Raritan, NJ 08869-0602
`
`
`Dear Mr. Truong:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated July 18, 2014, received
`July 18, 2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for XARELTO® (rivaroxaban) Tablets.
`
`We acknowledge receipt of your amendment dated January 9, 2015.
`
`This “Prior Approval” supplemental new drug application proposes the following change(s):
`update the Prescribing Information Section 2.8, Administration Options, to include information
`for rivaroxaban 10 mg crushed tablets.
`
`APPROVAL & LABELING
`
`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
`
`text.
`
`WAIVER OF HIGHLIGHTS SECTION
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of prescribing information.
`
`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 and Medication
`
`Reference ID: 3688029
`
`
`
`
`
`NDA 022406/S-012
`Page 2
`
`
`Guide), 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.
`
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Toni-Ann Cox, Regulatory Project Manager, at (240) 402-4775.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Ann T. Farrell, MD
`
`Director
`
`Division of Hematology Products
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE(S):
`Content of Labeling
`
`
`Reference ID: 3688029
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`ANN T FARRELL
`01/15/2015
`
`Reference ID: 3688029
`
`