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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21-436/S-034
`NDA 21-866/S-020
`NDA 21-713/S-025
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`NDA 21-729/S-018
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Otsuka Pharmaceutical Company, Ltd.
`Attention: David Goldberger
`Senior Director, Regulatory Affairs
`100 Overlook Center, 1st Floor
`Princeton, NJ 08540
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`Dear Mr. Goldberger:
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated and received August
`26, 2011 (S-034) and August 29, 2011 (S-020, S-025, S-018), submitted under section 505(b) of
`the Federal Food, Drug, and Cosmetic Act (FDCA) for Abilify (aripiprazole) Tablets, Orally
`Disintegrating Tablets, Oral Solution, and Injection.
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`We acknowledge receipt of your amendments dated November 29, 2011 and February 13, 2012.
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`This “Prior Approval” supplemental new drug application provides for the addition of a
`subsection entitled Metabolic Changes to the Warning and Precautions section of labeling.
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`We have completed our review of this supplemental application, as amended. 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 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), 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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`
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`Reference ID: 3091122
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`NDA 21-436/S-034
`NDA 21-866/S-020
`NDA 21-713/S-025
`NDA 21-729/S-018
`Page 2
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`The SPL will be accessible from publicly available labeling repositories.
`Also within 14 days, amend all pending supplemental applications 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, call Keith Kiedrow, Pharm.D., Senior Regulatory Project Manager, at
`(301) 796-1924.
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`Sincerely,
`
`{See appended electronic signature page}
`
`Thomas Laughren, M.D.
`Director
`
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
`Medication Guide
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`Reference ID: 3091122
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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
`02/22/2012
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`Reference ID: 3091122
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