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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022192/S-001
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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: Michelle Price McKern, Ph.D.
`Regional Brand Regulatory Manager
`Drug Regulatory Affairs – Neuroscience
`One Health Plaza
`East Hanover, NJ 07936-1080
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`Dear Dr. McKern:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received on June
`21, 2010, 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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`This “Changes Being Effected” supplemental new drug application provides for additional
`information regarding poor metabolizers of CYP2D6 to be incorporated into the Highlights
`Section, Section 2.2 (Dosage in Special Populations) and Section 12.3 (Pharmacokinetics) as
`requested in our Agency letter dated May 24, 2010.
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`We have completed our review of this supplemental 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 include the labeling changes
`proposed in any pending “Changes Being Effected” (CBE) supplements. Information on
`submitting SPL files using eLIST may be found in the guidance for industry titled “SPL
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`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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`NDA 022192/S-001
`Page 2
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` LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to 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, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA, to
`CDERMedWatchSafetyAlerts@fda.hhs.gov, and to the following address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
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`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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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, please 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 Laughren, M.D.
`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(S):
`Content of Labeling
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`Application
`Type/Number
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`NDA-22192
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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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`--------------------
`VANDA
`PHARMACEUTICA
`LS INC
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`------------------------------------------
`Fanapt
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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
`08/24/2010
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