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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDA 21-436 S-017
`NDA 21-713 S-012
`NDA 21-729 S-004
`NDA 21-866 S-004
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`Otsuka Pharmaceutical Company, Ltd.
`Attention: Kusuma Mallikaarjun, Ph.D.
`Senior Director, Regulatory Affairs
`2440 Research Blvd.
`Rockville, MD 20850
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`Dear Dr. Mallikaarjun:
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`Please refer to your March 23, 2007 supplemental new drug applications submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act for ABILIFY (aripiprazole) Tablets, ABILIFY
`DISCMELT Orally Disintegrating Tablets, ABILIFY Oral Solution, and ABILIFY Injection FOR
`INTRAMUSCULAR USE ONLY.
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`Your submission of September 28, 2007 to NDA 21-436 and your cross reference submission of
`October 4, 2007 to NDAs 21-713, 21-729, and 21-866 constituted a complete response to our action
`letter of September 25, 2007.
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`These supplemental new drug applications provide for the use of Abilify for the treatment of
`schizophrenia in adolescents aged 13-17.
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`We have completed our review of these applications, as amended. These applications are approved,
`effective on the date of this letter, for use as recommended in the agreed-upon labeling text.
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`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert,
`text for the patient package insert).
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`Within 21 days of the date of this letter, submit content of labeling [21 CFR 314.50(l)] in structured
`product labeling (SPL) format, as described at http://www.fda.gov/oc/datacouncil/spl.html, that is
`identical in content to the enclosed labeling text. Upon receipt, we will transmit that version to the
`National Library of Medicine for public dissemination. For administrative purposes, please designate
`this submission “SPL for approved supplement NDA 21-436/S-017, NDA 21-713 S-012, NDA 21-
`729 S-004, NDA 21-866 S-004.”
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`Please refer to the requests made in the cover letter of your September 28, 2007 submission –
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` •
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` We agree that individual or published case reports of serious occurrences of the subsumed adverse
`event terms will not need to be reported to the agency according to CFR 314.80 (c)(1)(i) Post
`Marketing 15 day “Alert Reports”.
`• We hereby grant a waiver for the half-page length requirement for the Highlights Section for the
`PLR format label, on this sNDA and future sNDA submissions.
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`NDA 21-436 S-017
`NDA 21-713 S-012
`NDA 21-729 S-004
`NDA 21-866 S-004
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`Page 2
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`In addition, submit three copies of the introductory promotional materials that you propose to use for
`these products. Submit all proposed materials in draft or mock-up form, not final print. Send one copy
`to this division and two copies of both the promotional materials and the package insert directly to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
`Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
`the following address:
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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, PharmD, Regulatory Project Manager, at (301) 796-
`1924.
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`Enclosure
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`Sincerely,
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`{See appended electronic signature page}
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`Thomas Laughren, M.D.
`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 Laughren
`10/29/2007 06:47:48 AM
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