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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDAs 21-436/S-030, 21-866/S-017, 21-713/S-022, 21-729/S-015
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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 October 20, 2010 and
`received on October 21, 2010, 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 letter dated November 11, 2009 where we requested that a comprehensive
`Medication Guide be submitted incorporating all relevant safety information related to
`aripiprazole. Also reference is made to your submission dated May 11, 2010 where you
`submitted a Medication Guide for FDA review, and FDA’s Complete Response letter dated
`August 6, 2010.
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`This Prior Approval supplement provides for revisions to the Medication Guide as we stated in
`our Complete Response letter dated August 6, 2010 and our email communication dated
`November 22, 2010. Based on our review of these supplemental applications they are approved,
`effective on the date of this letter, for use as recommended in the enclosed labeling text.
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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
`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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`Reference ID: 2870298
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`Sincerely,
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`{See appended electronic signature page}
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`Thomas Laughren, 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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` NDAs 21-436/S-030, 21-866/S-017, 21-713/S-022, 21-729/S-015
`Page 2
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`Also within 14 days, amend all pending supplemental applications for this NDA, including
`pending “Changes Being Effected” (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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`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: 2870298
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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
`11/30/2010
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`Reference ID: 2870298
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