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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021999/S-032
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` NDA 022264/S-024
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` NDA 207946/S-003
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`Food and Drug Administration
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` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` Janssen Pharmaceuticals, Inc.
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` Attention: Beth Geter-Douglass, Ph.D.
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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 Dr. Douglass:
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`Please refer to your Supplemental New Drug Applications (sNDA) dated and received December
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`9, 2016, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
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`for Invega (paliperidone) Extended-Release Tablets 1.5 mg, 3 mg, 6 mg, 9 mg, 12 mg (NDA
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`021999), Invega Sustenna (paliperidone palmitate) extended-release injectable suspension, 39
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`mg, 78 mg, 117 mg, 156 mg, and 234 mg (NDA 022264), and Invega Trinza (paliperidone
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`palmitate) extended-release injectable suspension 273 mg, 410 mg, 546 mg, 819 mg (NDA
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`207946).
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`We also refer to our letter dated November 10, 2016, notifying you, under Section 505(o)(4) of
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`the FDCA, of new safety information that we believe should be included in the labeling for
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`conventional and atypical antipsychotics. This information pertains to the risk of falls especially
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`for patients with diseases, conditions, or medications that could exacerbate these effects.
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`These supplemental new drug applications provide for revisions to the labeling for Invega,
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`Invega Sustenna, and Invega Trinza consistent with our November 10, 2016 safety labeling
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`change notification letter.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications. They are approved, effective
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`on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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`We note that your December 9, 2016, submission includes final printed labeling (FPL) for your
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`package insert (text for the patient package insert for Invega Sustenna and Invega Trinza). We
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`have not reviewed this FPL. You are responsible for assuring that the wording in this printed
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`labeling is identical to that of the approved content of labeling in the structured product labeling
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`(SPL) format.
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`Reference ID: 4060018
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` NDA 021999/S-032
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` NDA 022264/S-024
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` NDA 207946/S-003
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` Page 2
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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
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` 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
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` 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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` http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
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`patient package insert for Invega Sustenna and Invega Trinza), with the addition of any labeling
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`changes in 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 industry titled
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`“SPL Standard for Content of Labeling Technical Qs and As at
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`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
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`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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`changes approved in these supplemental applications, as well as annual reportable changes and
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`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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`should provide appropriate annotations, including supplement number(s) and annual report
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`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, new indications, new dosage forms, new dosing regimens, or new routes of
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` administration are required to contain an assessment of the safety and effectiveness of the
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` product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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` deferred, or inapplicable.
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`Reference ID: 4060018
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` NDA 021999/S-032
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` NDA 022264/S-024
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` NDA 207946/S-003
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` Page 3
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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
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` (21 CFR 314.80 and 314.81).
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`If you have any questions, please email Ann Sohn, Regulatory Project Manager, at
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`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
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`Division Director
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`Division of Psychiatry Products
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`Office of Drug Evaluation I
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`Center for Drug Evaluation and Research
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`ENCLOSURE:
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`Contents of Labeling
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`Reference ID: 4060018
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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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`MITCHELL V Mathis
`02/23/2017
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`Reference ID: 4060018
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