CENTER FOR DRUG EVALUATION AND RESEARCH
`
`Approval Package for:
`
`APPLICATION NUMBER:
`
`207202Orig1s000
`
`
`
`
`Trade Name:
`
` Abilify MyCite
`
`aripiprazole tablets with sensor
`
`Generic or Proper
`Name:
`
`Sponsor:
`
`
`
`
`Approval Date:
`
`
`Indication:
`
`
`
`
`Osuka Pharmaceutical Company, Ltd.
`
`November 13, 2017
`
`• Treatment of adults with schizophrenia
`• Treatment of bipolar I disorder
`• Acute treatment of adults with manic and mixed
`episodes as monotherapy and as adjunct to lithium or
`valproate
`• Maintenance treatment of adults as monotherapy and
`as adjunct to lithium or valproate
`• Adjunctive treatment of adults with major depressive
`disorder (MDD)
`
`
`
`

`

`CENTER FOR DRUG EVALUATION AND RESEARCH
`
`207202Orig1s000
`
`CONTENTS
`
`Reviews / Information Included in this NDA Review.
`
`
`
`Approval Letter
`Other Action Letters
`Labeling
`REMS
`Summary Review
`Officer/Employee List
`Office Director Memo
`Cross Discipline Team Leader Review
`Clinical Review(s)
`Product Quality Review(s)
`Non-Clinical Review(s)
`Statistical Review(s)
`Clinical Microbiology / Virology Review(s)
`Clinical Pharmacology Review(s)
`Other Reviews
`Risk Assessment and Risk Mitigation Review(s)
`Proprietary Name Review(s)
`Administrative/Correspondence Document(s)
`
`
`X
`X
`X
`
`X
`X
`
`
`X
`X
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`
`
`
`X
`
`X
`X
`
`

`

`
`
`
`
`
`
`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`207202Orig1s000
`
`
`APPROVAL LETTER
`
`

`

`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`NDA 207202
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`NDA APPROVAL
`
`
`Otsuka Pharmaceutical Company, Ltd.
`Attention: Michael Fahmy, M.S.
`Director, Global Regulatory Affairs
`Otsuka Pharmaceutical Development & Commercialization
`508 Carnegie Center Drive
`Princeton, NJ 08540
`
`
`Dear Mr. Fahmy:
`
`Please refer to your New Drug Application (NDA) dated and received June 26, 2015, and your
`amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`Abilify MyCite (aripiprazole tablets with sensor) 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg.
`
`We acknowledge receipt of your amendment dated April 21, 2017, which constituted a complete
`response to our April 26, 2016, action letter.
`
`This new drug application provides for the use of Abilify MyCite (aripiprazole tablets with
`sensor) to track drug ingestion of aripiprazole for the following indications:
`• Treatment of schizophrenia
`• Acute treatment of manic and mixed episodes associated with bipolar I disorder as
`monotherapy and as adjunct to lithium or valproate
`• Maintenance treatment of bipolar I disorder as monotherapy and as adjunct to lithium or
`valproate
`• Adjunctive treatment of major depressive disorder
`
`
`We have completed our review of this application, as amended. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
`
`We note that your November 13, 2017, submission includes final printed labeling (FPL) for your
`package insert and Medication Guide. We have not reviewed this FPL. You are responsible for
`assuring that the wording in this printed labeling is identical to that of the approved content of
`labeling in the structured product labeling (SPL) format.
`
`WAIVER OF HIGHLIGHTS SECTION
`
`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`prescribing information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
`
`
`Reference ID: 4180759
`
`

`

`NDA 207202
`Page 2
`
`
`CONTENT OF LABELING
`
`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). Information on submitting SPL files using eLIST may be found in the guidance for
`industry SPL Standard for Content of Labeling Technical Qs and As, available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`The SPL will be accessible via publicly available labeling repositories.
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`
`We acknowledge your November 13, 2017, submission containing final printed carton and
`container labels.
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
`
`This application triggers PREA because the use of the aripiprazole tablets with sensor is
`considered a new combination product. We note that for the drug alone, aripiprazole tablets,
`pediatric studies have been waived or fulfilled.
`
`We are waiving the pediatric study requirement as described below because necessary studies are
`impossible or highly impracticable:
`• Treatment of schizophrenia for ages birth to less than 13 years
`• Treatment of bipolar I disorder for ages birth to less than 10 years
`• Adjunctive treatment of major depressive disorder for ages birth to 6 years
`• Treatment of irritability associated with autistic disorder for ages birth to less than 6 years
`
`We are also waiving the pediatric study requirement for ages 7 to 17 years for the adjunctive
`treatment of major depressive disorder because Abilify MyCite is not likely to yield a
`meaningful therapeutic benefit over existing therapies for pediatric patients, and it is not likely to
`be used in a substantial number of pediatric patients.
`
`We are deferring submission of your pediatric studies for this application as described below
`because this product is ready for approval for use in adults and the pediatric studies have not
`been completed:
`
`Reference ID: 4180759
`
`

`

`NDA 207202
`Page 3
`
`
`
`• Treatment of schizophrenia for ages 13 to 17 years
`• Treatment of bipolar I disorder for ages 10 to 17 years
`• Treatment of irritability associated with autistic disorder for ages 6 to 17 years
`
`
`Your deferred pediatric studies required by section 505B(a) of the Federal Food, Drug, and
`Cosmetic Act are required postmarketing studies. The status of these postmarketing studies must
`be reported annually according to 21 CFR 314.81 and section 505B(a)(3)(C) of the Federal Food,
`Drug, and Cosmetic Act. These required studies are listed below.
`
`3290-1
`
`Conduct a human factors usability study using the to-be-marketed product in
`pediatric patients ages 13 to 17 years with schizophrenia, bipolar I disorder, and
`irritability associated with autistic disorder.
`
`12/2018
`12/2021
`12/2022
`
`Final Protocol Submission:
`Study Completion:
`
`Final Report Submission:
`
`Conduct a human factors usability study using the to-be-marketed product in
`pediatric patients with bipolar I disorder and irritability associated with autistic
`disorder ages 10 to 12 years and 6 to 12 years, respectively.
`
`
`
`3290-2
`
`
`
`Reference ID: 4180759
`
`Final Protocol Submission:
`Study Completion:
`
`Final Report Submission:
`
`12/2018
`12/2021
`12/2022
`
`
`Submit the protocols to your IND 115927, with a cross-reference letter to this NDA.
`
`Reports of these required pediatric postmarketing studies must be submitted as a new drug
`application (NDA) or as a supplement to your approved NDA with the proposed labeling
`changes you believe are warranted based on the data derived from these studies. When
`submitting the reports, please clearly mark your submission "SUBMISSION OF REQUIRED
`PEDIATRIC ASSESSMENTS" in large font, bolded type at the beginning of the cover letter
`of the submission.
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert,
`Medication Guide, and patient PI (as applicable) to:
`
`

`

`NDA 207202
`Page 4
`
`
`
`
`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`
`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
`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
`2253. Form FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, contact LT Brendan Muoio, Senior Regulatory Project Manager, at
`(240) 402-4518 or brendan.muoio@fda.hhs.gov.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Mitchell V. Mathis, MD
`Director
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`Enclosures:
`Content of Labeling
`Carton and Container Labeling
`
`
`
`Reference ID: 4180759
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MITCHELL V Mathis
`11/13/2017
`
`Reference ID: 4180759
`
`