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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 22264/S-013
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` NDA 22264/S-014
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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, Regulatory Affairs
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` 1125 Trenton-Harbourton Rd., E11710
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` Titusville, NJ 08560
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`Dear Dr. Geter-Douglass:
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`Please refer to your Supplemental New Drug Applications (sNDA) dated and received May 12,
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`2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
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`Invega Sustenna, (paliperidone palmitate) extended-release injectable suspension 39 mg, 78 mg,
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`117 mg, 156 mg, 234 mg.
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`We acknowledge receipt of your amendments dated June 26, 2014, and July 18, 2014.
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`These “Prior Approval” supplemental new drug applications propose the use of Invega Sustenna
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`for the treatment of schizoaffective disorder as monotherapy (S-013), and the use of Invega
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`Sustenna for the treatment of schizoaffective disorder as an adjunct to mood stabilizers or
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`antidepressants (S-014).
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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: 3657038
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` NDA 22264/S-013
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` NDA 22264/S-014
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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), 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
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`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 includes 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 this supplemental application, 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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`CARTON AND IMMEDIATE CONTAINER LABELS
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`We acknowledge your November 10, 2014, correspondence containing final printed carton and
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`container labels for the 39 mg strength. The same revisions should be applied to all strengths in
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`the product line.
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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, 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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`We are waiving the pediatric study requirement for this application because necessary studies are
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`impossible or highly impracticable.
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`Reference ID: 3657038
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` NDA 22264/S-013
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` NDA 22264/S-014
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` Page 3
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` PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
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`(3) the package insert(s) to:
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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, contact Sharonjit Sagoo, Pharm.D., Regulatory Project Manager, at
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`sharonjit.sagoo@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Mitchell V. Mathis, M.D.
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`CAPT, USPHS
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`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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`ENCLOSURES:
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`Content of Labeling
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`Carton and Container Labeling
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`Reference ID: 3657038
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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
`11/12/2014
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`Reference ID: 3657038
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