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`Food and Drug Administration
`Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022192/S-002
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`Reference ID: 2870684
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`Novartis Pharmaceuticals Corporation
`Attention: Michelle Price McKern, Ph.D.
`Regional Brand Regulatory Manager
`One Health Plaza
`East Hanover, NJ 07936
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`Dear Dr. McKern:
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`Please refer to your Supplemental New Drug Application (sNDA) dated September 22, 2010,
`received September 22, 2010, submitted under section 505(b)/pursuant to section 505(b)(2) of
`the Federal Food Drug, and Cosmetic Act (FDCA) for Fanapt (iloperidone) 1 mg, 2 mg, 4 mg, 6
`mg, 8 mg, 10 mg, and 12 mg Tablets..
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`We acknowledge receipt of your amendment dated November 18, 2010.
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`We also refer to our letter dated August 23, 2010, notifying you, under Section 505(o)(4) of the
`FDCA, of new safety information that we believe should be included in the labeling for
`antipsychotics, including Fanapt (iloperidone). This information pertains to the risk of EPS and
`withdrawal syndrome in neonates, with the use of the class of antipsychotics by the mothers,
`based on new safety information about this risk identified since the product was approved.
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`This supplemental new drug application provides for revisions to the labeling for Fanapt
`(iloperidone) consistent with our August 23, 2010, letter.
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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, text for the patient package insert,
`Medication Guide) and include the labeling changes proposed in any pending “Changes Being
`Effected” (CBE) supplements. Information on submitting SPL files using eLIST may be found
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`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 022192/S002
`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
`pending “Changes Being Effected” (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.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.(b)(3)(i)]. Form FDA
`2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html; instructions
`are provided on page 2 of the form. For more information about submission of promotional
`materials to the Division of Drug Marketing, Advertising, and Communications (DDMAC), see
`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`All promotional materials that include representations about your drug product must be promptly
`revised to be consistent with the labeling changes approved in this supplement, including any
`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
`should include prominent disclosure of the important new safety information that appears in the
`revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
`to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
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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
`Food and Drug Administration
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`Reference ID: 2870684
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`Sincerely,
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`{See appended electronic signature page}
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`Thomas 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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`NDA 022192/S002
`Page 3
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`10903 New Hampshire Ave
`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, call Kimberly Updegraff, M.S., Regulatory Project Manager, at
`(301)796-2201.
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 2870684
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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
`12/01/2010
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`Reference ID: 2870684
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