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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21436/S-040
`NDA 21713/S-031
`NDA 21729/S-023
`NDA 21866/S-025
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`NDA 202971/S-008
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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.
`Attention: Dana Cahill, PhD
`Associate Director, Global Regulatory Affairs
`2440 Research Blvd.
`Rockville, MD 20850
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`Dear Dr. Cahill:
`
`Please refer to your Supplemental New Drug Applications (sNDA) dated and received January 8,
`2016, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
`Abilify (aripiprazole) 2, 5, 10, 15, 20, 30 mg tablets (NDA 21436); Abilify (aripiprazole) 1
`mg/mL oral solution (NDA 21713); Abilify (aripiprazole) 10 and 15 mg Orally Disintegrating
`Tablets (NDA 21729); Abilify (aripiprazole) 9.75 mg/1.3 mL injection for IM use (NDA 21866);
`Abilify Maintena (aripiprazole) for extended-release injectable suspension, for intramuscular
`injection 300 mg/vial and 400 mg/vial (NDA 202971).
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`These “Changes Being Effected” supplemental new drug applications provide for the addition of
`pathological gambling and hiccups to section 6.2 Postmarketing Experience.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications. They are approved, effective
`on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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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
`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
`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
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`Reference ID: 3874224
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`NDAs 21436/S-040; 21713/S-031; 21729/S-023; 21866/S-025; 202971/S-008
`Page 2
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`of labeling must be identical to the enclosed labeling (text for the package insert, 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 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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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`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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`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 email Simran Parihar, PharmD, Regulatory Health Project
`Manager, at simran.parihar@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
`
`
`Mitchell V. Mathis, 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:
`Content of Labeling
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`Reference ID: 3874224
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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
`01/15/2016
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`Reference ID: 3874224
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