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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`NDA 22264/S-001
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`Ortho-McNeil-Jansen Pharmaceuticals, Inc.
`Attention: Rodney Malchow, J.D.
`Associate Director, Regulatory Affairs
`1125 Trenton-Harbourton Road
`P.O. Box 200
`Titusville, N.J. 80560
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`Dear Mr. Malchow:
`
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`Please refer to your Supplemental New Drug Application (sNDA), dated and received April 2,
`2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Invega Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension.
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`This Changes Being Effected supplemental new drug application provides for the following
`revisions to product labeling:
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`1. Under Adverse Reactions: Subsections 6.1 (Incidence if Treatment Emergent Adverse Events
`in ≥2% of INVEGA® SUSTENNA®-Treated Subjects with Schizophrenia in Four Fixed-
`Dose, Double-Blind, Placebo-Controlled Trials ), 6.2 (Adverse Reactions Observed During
`the Clinical Trial Evaluation of INVEGA® SUSTENNA® and Not Listed in Table 2), 6.9
`(Adverse Reactions in Clinical Trials with Oral Paliperidone), & a new subsection 6.10
`(Postmarketing Experience).
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`2. Under Overdosage: Subsection 10.1 (Human Experience)
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`3. Throughout labeling, “TM” replaced with “®”.
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`We have completed our review of this application. 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, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling [21 CFR
`314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling (text for the package insert, and Medication Guide).
`Information on submitting SPL files using eLIST may be found in the guidance for industry
`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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`

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`NDA 22264/S-001
`Page 2
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`The SPL will be accessible via publicly available labeling repositories.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you issue a letter communicating important safety related information about this drug product
`(i.e., a “Dear Health Care Professional” letter), we request that you submit an electronic copy of
`the letter to both this NDA and to the following address:
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`MedWatch
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`Food and Drug Administration
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`5600 Fishers Lane, Room 12B05
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`Rockville, MD 20857
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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, email Ann Sohn, Regulatory Project Manager, at
`ann.sohn@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Thomas Laughren, M.D.
`Director
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`Division of Psychiatry Products
`Office of Drug Evaluation 1
`Center for Drug Evaluation and Research
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`Enclosure
`Content of Labeling
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`

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`Application
`Type/Number
`--------------------
`NDA-22264
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`Submission
`Type/Number
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`SUPPL-1
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`Submitter Name
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`Product Name
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`------------------------------------------
`Invega Sustenna
`
`--------------------
`JOHNSON AND
`JOHNSON
`PHARMACEUTICA
`L RESEARCH AND
`DEVELOPMENT
`LLC
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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/
`----------------------------------------------------
`
`THOMAS P LAUGHREN
`05/13/2010
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