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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-013
`NDA 21-713 / S-008
`NDA 21-729 / S-001
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`Otsuka Maryland Research Institute
`Attention: Kusuma Mallikaarjun, Ph.D.
`Senior Director, Regulatory Affairs
`2440 Research Boulevard
`Rockville, MD 20850
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`Dear Dr. Mallikaarjun:
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`Please refer to your supplemental new drug applications dated and received June 30, 2005, submitted
`under section 505 of the Federal Food, Drug, and Cosmetic Act for Abilify (aripiprazole) Tablets and
`Abilify (aripiprazole) Oral Solution.
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`Refer also to your supplement dated July 7, 2006, received July 10, 2006 for Abilify Discmelt
`(aripiprazole) Orally Disintegrating Tablets.
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`These supplemental new drug applications provide for revisions (under PRECAUTIONS: Drug-Drug
`Interactions) based on the results of two pharmacokinetic interaction studies (CN138126 and
`CN138127).
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`We have completed our review of these applications, as amended, and they are approved, effective on
`the date of this letter, for use as recommended in the submitted labeling text.
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`The final printed labeling (FPL) must be identical to the submitted labeling (package insert submitted
`July 7, 2006 – copy attached). Since the entire Abilify product line utilizes the same package insert,
`we request that you update the Abilify Injection NDA with the amended labeling information in your
`next annual report.
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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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`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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`NDA 21-436 / S-013
`NDA 21-713 / S-008
`NDA 21-729 / S-001
`Page 2
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`If you have any questions, call Keith Kiedrow, Pharm.D., Regulatory Project Manager, at (301) 796-
`1924.
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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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`Enclosure (labeling)
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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
`10/20/2006 03:27:28 PM
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