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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022192/S-005/S-006
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Novartis Pharmaceuticals Corporation
`Attention: Sara Kessler, MBA
`Drug Regulatory Affairs – Neuroscience
`One Health Plaza
`East Hanover, NJ 07936-1080
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`Dear Ms. Kessler:
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`Please refer to your Supplemental New Drug Applications (sNDA) dated and received May 5,
`2011 (S-005), and June 10, 2011 (S-006), submitted under section 505(b) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for Fanapt (iloperidone) oral tablets 1 mg, 2 mg, 4 mg, 6 mg, 8
`mg, 10 mg, and 12 mg.
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`S-005
`This “Prior Approval” supplemental new drug application provides for revisions to sections 12.3
`(Pharmacokinetics) & 13.1 (Carcinogenesis) as requested in an Agency supplement request letter
`dated April 22, 2011.
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`S-006
`This “Changes Being Effected” supplemental new drug application provides for the addition of a
`new Post Marketing Experience subsection, 6.2.
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`We have completed our review of these supplemental applications. They are approved, effective
`on the date of this letter. The agreed-upon labeling is attached.
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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 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
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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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`Reference ID: 3011034
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` NDA 022192/S-005/S-006
`Page 2
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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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`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 questions, call Kimberly Updegraff, M.S., Senior Regulatory Project Manager, at
`(301)796-2201.
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`Sincerely,
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`{See appended electronic signature page}
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`Thomas P. Laughren, M.D.
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`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: 3011034
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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
`09/07/2011
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`Reference ID: 3011034
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