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`Food and Drug Administration
`Silver Spring, MD 20993
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`SUPPLEMENT APPROVAL
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 021999/S-035
`NDA 022264/S-027
`NDA 207946/S-006
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`Janssen Pharmaceuticals, Inc.
`Attention: Beth Geter-Douglass, PhD
`Associate Director, Global Regulatory Affairs
`1125 Trenton-Harbourton Road
`Titusville, NJ 08560
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`Dear Dr. Douglass:
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`Please refer to your Supplemental New Drug Applications (sNDA) dated and received
`November 17, 2017, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act (FDCA) for Invega (paliperidone) Extended-Release Tablets 1.5 mg, 3 mg, 6 mg, and 9 mg
`(NDA 021999), Invega Sustenna (paliperidone palmitate) extended-release injectable
`suspension, 39 mg, 78 mg, 117 mg, 156 mg, and 234 mg (NDA 022264), and Invega Trinza
`(paliperidone palmitate) extended-release injectable suspension 273 mg, 410 mg, 546 mg, 819
`mg (NDA 207946).
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`These Prior Approval supplemental new drug applications provide for revisions to the US
`Prescribing Information (USPI) as required according to Content and Format of Labeling for
`Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation
`Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR, or final rule).
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications. They are approved, effective
`on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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`WAIVER OF HIGHLIGHTS SECTION
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`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.
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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
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`Reference ID: 4298398
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`

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`NDA 021999/S-035
`NDA 022264/S-027
`NDA 207946/S-006
`Page 2
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`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
`patient package insert for Invega Sustenna and Invega Trinza), 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.
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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 include 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 these supplemental applications, 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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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients (which includes new salts and new fixed combinations), 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 in pediatric
`patients unless this requirement is waived, deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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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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`Reference ID: 4298398
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`NDA 021999/S-035
`NDA 022264/S-027
`NDA 207946/S-006
`Page 3
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`If you have any questions, please email Ann Sohn, Regulatory Project Manager, at
`ann.sohn@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Mitchell V. Mathis, MD
`Division Director
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Contents of Labeling
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`Reference ID: 4298398
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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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`MITCHELL V Mathis
`07/27/2018
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`Reference ID: 4298398
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