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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 22264/S-005
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Janssen Pharmaceuticals, Inc.
`Attention: Rodney Malchow, J.D.
`Associate Director, Global Regulatory Affairs
`920 Route 202, P.O. Box 300
`Raritan, NJ 08869
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`Dear Mr. Malchow:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received on March
`14, 2011, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for Invega Sustenna (paliperidone palmitate) extended-release injectable suspension, 39 mg, 78
`mg, 117 mg, 156 mg, and 234 mg.
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`We acknowledge receipt of your amendments dated July 3, 2012, and July 20, 2012, and email
`correspondences dated August 23, 2012, and August 27, 2012, from you providing for agreed
`upon labeling changes.
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`The July 3, 2012, submission constituted a complete response to our January 13, 2012, action
`letter.
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`This “Prior Approval” supplemental new drug application proposes labeling changes to Section 2
`– Dosage and Administration regarding missed doses. Additionally, based upon the Agency’s
`review of your product labeling, additional changes were made to the Boxed Warning,
`Indications and Usage, Warnings and Precautions and Use in Specific Populations sections as
`well as corresponding changes to the Highlights section.
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the 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 labeling.
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`Reference ID: 3181708
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` NDA 22264/S-005
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`Page 2
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`Information on submitting SPL files using eLIST may be found in the guidance for industry
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` 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 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 this
`supplemental application, 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, 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(s) 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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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`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/opacom/morechoices/fdaforms/cder.html;
`instructions are provided on page 2 of the form. For more information about submission of
`promotional materials to the Office of Prescription Drug Promotion (OPDP), see
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`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`Reference ID: 3181708
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` NDA 22264/S-005
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`Page 3
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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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`If you have any questions, contact Sharonjit Sagoo, Regulatory Project Manager, at
`sharonjit.sagoo@fda.hhs.gov.
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`Sincerely,
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` {See appended electronic signature page}
`
`Thomas Laughren, M.D.
`Division Director
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 3181708
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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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`THOMAS P LAUGHREN
`08/29/2012
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`Reference ID: 3181708
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