`SERVICES
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`NDA 022192/S-004
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`Public Health Service
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` Food and Drug Administration
`Rockville, MD 20857
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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 Application (sNDA) dated and received on
`December 13, 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 “Prior Approval” labeling supplemental new drug application proposes to remove the word
`“acute” from the Highlights and Indications and Usage sections of labeling.
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`We have completed our review of this supplemental application. It is 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 (text for the package insert and Medication
`Guide), 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
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
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`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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`Reference ID: 2921042
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`NDA 022192/S-004
`Page 2
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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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`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 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 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.
`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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`Reference ID: 2921042
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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
`03/21/2011
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`Reference ID: 2921042
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