NDA 021999/S-037
`NDA 022264/S-030
`NDA 207946/S-009
`
`
`
`SUPPLEMENT APPROVAL
`
`
`Janssen Research & Development, LLC
`Attention: Beth Geter-Douglass, PhD
`Associate Director, Regulatory Affairs
`1125 Trenton-Harbourton Road
`Titusville, NJ 08560
`
`
`Dear Dr. Geter-Dougass:
`
`Please refer to your supplemental new drug applications (sNDAs) dated and received
`July 25, 2018, and your amendments, submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for Invega (paliperidone) extended-release
`tablets (NDA 021999), Invega Sustenna (paliperidone palmitate) extended-release
`injectable suspension (NDA 022264), and Invega Trinza (paliperidone palmitate)
`extended-release injectable suspension (NDA 207946).
`
`We acknowledge receipt of your amendment dated October 11, 2019, which constituted
`a complete response to our January 25, 2019, action letter.
`
`These Prior Approval supplemental new drug applications provide for the following
`revisions to the Prescribing Information:
`
`Invega (paliperidone palmitate) extended-release tablets: The term “catatonia” was
`added to Adverse Reactions-Postmarketing Experience (Section 6.2) and revisions
`were made to Warnings and Precautions (Section 5) and Patient Counseling (Section
`17) to align with class labeling language. In addition, terms were added to Adverse
`Reactions-Postmarketing Experience (Section 6.2) and Use in Specific Populations
`
`(Section 8.8) was added to align with revisions in Warnings and Precautions.
`
`Invega Sustenna (paliperidone palmitate) extended-release injectable suspension: The
`term “catatonia” was added to Adverse Reactions-Postmarketing Experience (Section
`6.2), “in single-dose prefilled syringes” was added to Dosage Forms and Strengths
`(Section 3), “single-dose” was added to Description (Section 11), and revisions were
`made to Section 5 (Warnings and Precautions) and Section 17 (Patient Counseling) to
`align with class labeling language. In addition, Drug Interactions (Section 7) was revised
`to align with other paliperidone labeling.
`
`Invega Trinza (paliperidone palmitate) extended-release injectable suspension: The
`term “catatonia” was added to Adverse Reactions-Postmarketing Experience (Section
`
`Reference ID: 4729447
`
`

`

`NDA 021999/S-037
`NDA 022264/S-030
`NDA 207946/S-009
`Page 2
`
`
`6.2), “in single-dose prefilled syringes” was added to Dosage Forms and Strengths
`(Section 3), “single-dose” was added to Description (Section 11), and revisions were
`made to Warnings and Precautions (Section 5) and Patient Counseling (Section 17) to
`align with class labeling language. In addition, Drug Interactions (Section 7) was revised
`to align with other paliperidone labeling.
`
`APPROVAL & LABELING
`
`We have completed our review of these applications, as amended. They are approved,
`effective on the date of this letter, for use as recommended in the enclosed agreed-
`upon labeling.
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`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
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information and 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.
`
`
`Information on submitting SPL files using eList may be found in the guidance for
`
` industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`The SPL will be accessible from publicly available labeling repositories.
`
`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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`Reference ID: 4729447
`
`

`

`NDA 021999/S-037
`NDA 022264/S-030
`NDA 207946/S-009
`Page 3
`
`
`Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
`
`CARTON AND CONTAINER LABELING
`
`
`We acknowledge your April 1, 2020 and April 9, 2020, submissions containing final
`
`printed carton and container labeling for Invega Sustenna and Invega Trinza.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`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.
`
`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, email Ann Sohn, Regulatory Project Manager, at
`
`ann.sohn@fda.hhs.gov.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Tiffany R. Farchione, MD
`Director
`Division of Psychiatry
`Office of Neuroscience
`Center for Drug Evaluation and Research
`
`
`ENCLOSURES:
`
` Content of Labeling
`
`o Prescribing Information
`
`o Patient Package Insert
`
`
` Carton and Container Labeling
`
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`Reference ID: 4729447
`
`

`

`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/
`------------------------------------------------------------
`
`TIFFANY R FARCHIONE
`02/12/2021 06:07:47 PM
`
`Reference ID: 4729447
`
`(
`
`
`
`