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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021436/S-041
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` NDA 021713/S-032
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` NDA 021729/S-024
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` NDA 021866/S-026
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` NDA 202971/S-009
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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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`Otsuka Pharmaceutical Development & Commercialization, Inc.
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`U.S. Agent for Otsuka Pharmaceutical Company, Ltd.
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`Attention: Dana Cahill, PhD
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`Associate Director, Global Regulatory Affairs
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`2440 Research Boulevard
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`Rockville, MD 20850
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`Dear Dr. Cahill:
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`Please refer to your Supplemental New Drug Applications (sNDA) dated and received July 14,
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`2016, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
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`Abilify (aripiprazole) 2, 5, 10, 15, 20, 30 mg tablets (NDA 021436); Abilify (aripiprazole)
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`1 mg/mL oral solution (NDA 021713); Abilify (aripiprazole) 10 and 15 mg Orally Disintegrating
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`Tablets (NDA 021729); Abilify (aripiprazole) 9.75 mg/1.3 mL injection for IM use (NDA
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`021866); Abilify Maintena (aripiprazole) for extended-release injectable suspension, for
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`intramuscular injection 300 mg/vial and 400 mg/vial (NDA 202971).
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`We also refer to our letter dated May 3, 2016, notifying you, under Section 505(o)(4) of the
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`FDCA, of new safety information that we believe should be included in the labeling for
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`aripiprazole, pertaining to the risk of impulse-control problems.
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`These supplemental new drug applications provide for revisions to the to the Highlights,
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`Warnings and Precautions (5), Patient Counseling Information section (17), and Medication
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`Guide consistent with our May 3, 2016 letter.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended. They are
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`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
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`We note that your July 14, 2016, submission includes final printed labeling (FPL) for your
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`package insert and Medication Guide. We have not reviewed this FPL. You are responsible for
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`Reference ID: 3964103
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` NDAs 021436/S-041, 021713/S-032, 021729/S-024, 021866/S-026, and 202971/S-009
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` Page 2
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` assuring that the wording in this printed labeling is identical to that of the approved content of
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` labeling in the structured product labeling (SPL) format.
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`WAIVER OF HIGHLIGHTS SECTION
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` Please note that we have previously granted a waiver of the requirements of 21 CFR
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` 201.57(d)(8) regarding the length of Highlights of prescribing information.
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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
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` http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling (text for the package insert and Medication
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`Guide), with the addition of any labeling changes in pending “Changes Being Effected” (CBE)
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`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
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`“SPL Standard for Content of Labeling Technical Qs and As at
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`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 include labeling changes
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`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
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`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-
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`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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`should provide appropriate annotations, including supplement number(s) and annual report
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`date(s).
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
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`(3) the package insert(s) to:
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`Reference ID: 3964103
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` NDAs 021436/S-041, 021713/S-032, 021729/S-024, 021866/S-026, and 202971/S-009
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` Page 3
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` OPDP Regulatory Project Manager
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` Food and Drug Administration
` Center for Drug Evaluation and Research
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` Office of Prescription Drug Promotion (OPDP)
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` 5901-B Ammendale Road
` Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
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` Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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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 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
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`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
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`more information about submission of promotional materials to the Office of Prescription Drug
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`Promotion (OPDP), 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
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`revised to be consistent with the labeling changes approved in this supplement, including any
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`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
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`should include prominent disclosure of the important new safety information that appears in the
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`revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
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`to comply with 21 CFR 314.70(a)(4) to the address above, by fax to 301-847-8444, or
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`electronically in eCTD format. For more information about submitting promotional materials in
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`eCTD format, see the draft Guidance for Industry (available at:
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`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`Reference ID: 3964103
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`Sincerely,
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`{See appended electronic signature page}
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`Mitchell V. Mathis, MD
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`Director
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`Division of Psychiatry Products
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`Office of Drug Evaluation I
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`Center for Drug Evaluation and Research
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` NDAs 021436/S-041, 021713/S-032, 021729/S-024, 021866/S-026, and 202971/S-009
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` Page 4
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` If you have any questions, contact Danbi Lee, Regulatory Project Manager, at (240) 402-8986.
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`ENCLOSURE:
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`Content of Labeling
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`Reference ID: 3964103
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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
`08/18/2016
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`Reference ID: 3964103
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