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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 021436/S-042
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` NDA 021713/S-033
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` NDA 021729/S-025
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` NDA 021866/S-027
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` NDA 202971/S-011
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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 December 8, 2016,
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`received December 8, 2016, and your amendment, submitted under section 505(b) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for Abilify (aripiprazole) 2, 5, 10, 15, 20, 30 mg tablets
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`(NDA 021436); Abilify (aripiprazole) 1 mg/mL oral solution (NDA 021713); Abilify
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`(aripiprazole) 10 and 15 mg Orally Disintegrating Tablets (NDA 021729); Abilify (aripiprazole)
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`9.75 mg/1.3 mL injection for IM use (NDA 021866); Abilify Maintena (aripiprazole) for
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`extended-release injectable suspension, for intramuscular injection 300 mg/vial and 400 mg/vial
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`(NDA 202971).
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`We also refer to our letter dated November 10, 2016, notifying you, under Section 505(o)(4) of
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`the FDCA, of new safety information that we believe should be included in the labeling for
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`conventional and atypical antipsychotics. This information pertains to the risk of falls especially
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`for patients with diseases, conditions, or medications that could exacerbate these effects.
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`These supplemental new drug applications provide for revisions to the labeling for Abilify and
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`Abilify Maintena consistent with our November 10, 2016 safety labeling change notification
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`letter.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications. They are approved, effective
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`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 January 20, 2017, 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: 4059985
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` NDAs 021436/S-042, 021713/S-033, 021729/S-025, 021866/S-027, 202971/S-011
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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
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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
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`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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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`Reference ID: 4059985
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` NDAs 021436/S-042, 021713/S-033, 021729/S-025, 021866/S-027, 202971/S-011
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` Page 3
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` Because none of these criteria apply to your application, you are exempt from this requirement.
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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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`If you have any questions, contact Danbi Lee, Regulatory Project Manager, at
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`danbi.lee@fda.hhs.gov.
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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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`Division 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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`ENCLOSURE:
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`Contents of Labeling
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`Reference ID: 4059985
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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
`02/23/2017
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`Reference ID: 4059985
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