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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021999/S-036
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` NDA 022264/S-029
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` NDA 207946/S-008
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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, PhD
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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 March 20,
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`2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Invega (paliperidone) Extended-Release Tablets 1.5 mg, 3 mg, 6 mg,
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`and 9 mg (NDA 021999), Invega Sustenna (paliperidone palmitate) extended-release injectable
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`suspension, 39 mg, 78 mg, 117 mg, 156 mg, and 234 mg (NDA 022264), and Invega Trinza
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`(paliperidone palmitate) extended-release injectable suspension 273 mg, 410 mg, 546 mg, 819
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`mg (NDA 207946).
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`These “Changes Being Effected” supplemental new drug applications provide for revisions to the
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`Postmarketing Experience section.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended. They are
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`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
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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
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`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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`Reference ID: 4381249
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` NDA 021999/S-036
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` NDA 022264/S-029
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` NDA 207946/S-008
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` Page 2
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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
` 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
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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` 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
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`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
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`assessment of the safety and effectiveness of the product for the claimed indication in pediatric
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`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
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`(21 CFR 314.80 and 314.81).
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`Reference ID: 4381249
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` NDA 021999/S-036
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` NDA 022264/S-029
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` NDA 207946/S-008
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` Page 3
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` If you have any questions, please email Simran Parihar, PharmD, at simran.parihar@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Tiffany Farchione, MD
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`Division Director (Acting)
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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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`Prescribing Information
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`Patient Package Insert
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`Reference ID: 4381249
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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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`TIFFANY R FARCHIONE
`01/25/2019 01:08:41 PM
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`Reference ID: 4381249
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