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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 21-729
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`
`Otsuka Pharmaceutical Co., Ltd.
`Attention: Kusuma Mallikaarjun, Ph.D.
`2440 Research Boulevard
`Rockville, MD 20850
`
`Dear Dr. Mallikaarjun:
`
`Please refer to your new drug application (NDA) dated and received December 22, 2003 under section
`505(b) of the Federal Food, Drug, and Cosmetic Act for Abilify Discmelt (aripiprazole orally
`disintegrating tablets).
`
`Your submission dated December 12, 2005, and received December 13, 2005, constituted a complete
`response to our October 22, 2004, action letter.
`
`This new drug application provides for the use of Abilify Discmelt (aripiprazole orally disintegrating
`tablets) for the treatment of schizophrenia and for the treatment of acute manic and mixed episodes
`associated with bipolar disorder.
`
`We completed our review of this application, as amended. It is approved, effective on the date of this
`letter, for use as recommended in the agreed-upon labeling text.
`
`The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert).
`Marketing the products with FPL that is not identical to the approved labeling text may render the
`product misbranded and an unapproved new drug.
`
`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format - NDA. For administrative purposes, designate this
`submission “FPL for approved NDA 21-729.” Approval of this submission by FDA is not required
`before the labeling is used.
`
` A
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` 24 month expiry date is granted based upon the available stability data.
`
`
`With regards to regulatory test methods, the proposal for an interim specification of Q NLT --- % in 30
`(b)(4)
`minutes is acceptable. However, full dissolution profiles for at least---- batches or batches produced
`(b)(4)
`for 12 months, whichever comes first, should be provided and should also account for data indicating
`how many------------- would be performed if the specification were to be set at Q NLT --- %. A final
`(b)(4)
`(b)(4)
`specificati--- ---------- et after the data is provided and reviewed. This should be provided within 16
`months of the date of this letter.
`
`The Division of Medication Errors and Technical Support (DMETS) has recently reviewed your
`container and carton labeling and their recommendations are attached to this letter.
`
`
`
`

`

`NDA 21-483
`Page 2
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`All applications for new active ingredients, new dosage forms, new indications, new routes of
`administration, and new dosing regimens are required to contain an assessment of the safety and
`effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are
`waiving the pediatric study requirement for this application.
`
`
`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., Regulatory Project Manager, at (301) 796-
`1924.
`
`
`
`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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`Enclosures (DMETS recommendations and product labeling)
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`
`

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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/
`---------------------
`Thomas Laughren
`6/7/2006 03:58:40 PM
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`