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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDAs 21-436/S-032, 21-866/S-019, 21-713/S-024, 21-729/S-017
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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: David Goldberger
`Senior Director, Regulatory Affairs
`100 Overlook Center, 1st Floor
`Princeton, NJ 08540
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`Dear Mr. Goldberger:
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`Please refer to your Supplemental New Drug Applications (sNDAs) dated February 22, 2011,
`received February 22, 2011 and February 23, 2011, submitted under section 505(b) of the
`Federal Food Drug, and Cosmetic Act (FDCA) for Abilify (aripiprazole) tablet, oral solution,
`orally disintegrating tablet, and injectable formulation.
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`We also refer to our electronic correspondence dated June 6, 2008 and your response dated
`October 6, 2008 regarding the influence of simultaneous inhibition of CYP2D6 and CYP3A4
`isozymes on aripiprazole pharmacokinetics. Further reference is made to our Changes Being
`Effected (CBE) supplement request letter dated January 20, 2011.
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`This CBE supplemental new drug application provides for revisions to the labeling for Abilify
`(aripiprazole) tablet, oral solution, orally disintegrating tablet, and injectable formulation
`consistent with our January 20, 2011, letter.
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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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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling (text for the package insert and Medication Guide) and include
`the labeling changes proposed in any pending “Changes Being Effected” (CBE) supplements.
`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`titled “SPL Standard for Content of Labeling Technical Qs and As” at
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`Reference ID: 2912460
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` NDAs 21-436/S-032, 21-866/S-019, 21-713/S-024, 21-729/S-017
`Page 2
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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 for this NDA, including
`pending 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.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA to the following
`address:
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`MedWatch Program
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`Office of Special Health Issues
`Food and Drug Administration
`10903 New Hampshire Ave
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` Building 32, Mail Stop 5353
`Silver Spring, MD 20993
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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 Sonny Saini, Pharm.D., MBA, Regulatory Project Manager, at
`(301) 796-0532.
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 2912460
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`Sincerely,
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`{See appended electronic signature page}
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`Thomas Laughren, M.D.
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`Director
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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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
`03/02/2011
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`Reference ID: 2912460
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