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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21999/S-029
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`NDA 22264/S-010
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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.
`Attention: Beth Geter-Douglas, Ph.D.
`Associate Director, Global Regulatory Affairs
`1125 Trenton-Harbourton Road
`E11710
`Titusville, NJ 08560
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`Dear Dr. Geter-Douglas:
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`Please refer to your Supplemental New Drug Applications (sNDAs) dated April 25, 2013and
`received April 26, 2013, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Invega (paliperidone) tablets, and Invega Sustenna (paliperidone)
`extended-release suspension for intramuscular injection.
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`We acknowledge receipt of your amendments dated November 12, 2013.
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`The November 12, 2013 submissions constituted a complete response to our September 25,
`2013, action letter.
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`These “Prior Approval” supplemental new drug applications propose the following:
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`1. Text to clarify that carbamazepine is a strong inducer of both CYP3A4 and P-
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`glycoprotein in the INVEGA® and INVEGA® SUSTENNA® labels
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`2. The addition of the term “ileus” to the appropriate alphabetical location in the sentence
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`that lists adverse reactions in the Postmarketing Experience sections of the INVEGA®
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`and INVEGA® SUSTENNA® labels.
`3. The addition of the following sentence to the INVEGA® SUSTENNA® label, Section
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`6.2: “Very rarely, cases of anaphylactic reaction after injection with INVEGA®
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`SUSTENNA® have been reported during postmarketing experience in patients who have
`previously tolerated oral risperidone or oral paliperidone.”
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications. They are approved, effective
`on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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`Reference ID: 3495576
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`NDA 21999/S-029
`NDA 22264/S-010
`Page 2
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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
`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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`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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`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
`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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`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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`Reference ID: 3495576
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`NDA 21999/S-029
`NDA 22264/S-010
`Page 3
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`If you have any questions, please 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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`
`Mitchell V. Mathis, M.D.
`CAPT, USPHS
`Director
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`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: 3495576
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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
`04/29/2014
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`Reference ID: 3495576
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