`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`2 1 -729
`
`APPROVAL LETTER
`
`
`
`i «mmH ,,
`
`Mr,“I. {( DEPARTMENTOFHEALTH&HUMANSERVICES
`
`""2...“
`
`
`Food and Drug Administration
`Rockville. MD 20857
`
`PublicHealthService
`
`NDA 21-729
`
`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 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 ‘l in 30
`minutes is acceptable. However, full dissolution profiles for at least —.batches or batches produced
`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
`specification. will be set 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
`
`All applications for new active ingredients, new dosage forms, n‘ew 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).
`
`If you have any questions, call Keith Kiedrow, Pharm.D., Regulatory Project Manager, at (301) 796-
`1924.
`
`Sincerely,
`
`{Sec appended electronic signature page}
`
`Thomas Laughren, MD.
`Director
`
`Division of Psychiatry Products
`Office of Drug Evaluation'l
`Center for Drug Evaluation and Research _
`
`Enclosures (DMETS recommendations and product labeling)
`
`
`
`_____________________________________________________________________________________________________________________
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Thomas Laughren
`6/7/2006 03:58:40 PM
`
`