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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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`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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`NDA 21-436 / S-016
`NDA 21-713 / S-010
`NDA 21-729 / S-002
`NDA 21-866 / S-003 / S-002
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`Otsuka Maryland Research Institute, Inc.
`Attention: Kusuma Mallikaarjun, Ph.D.
`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 November 14, 2006, received
`November 15, 2006, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`Abilify (aripiprazole) Tablets, DISCMELT, Oral Solution, and Injection for Intramuscular Use.
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`These “Changes Being Effected” supplemental new drug applications provide for the addition of the
`terms oropharyngeal spasm, grand mal seizure and jaundice under the Other Events Observed
`During the Postmarketing evaluation of Aripiprazole subsection of the ADVERSE REACTIONS
`section of Abilify labeling.
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`We have completed our review of these supplemental new drug applications and they are approved,
`effective on the date of this letter, for use as recommended in the final printed labeling (FPL)
`submitted on November 14, 2006 (copy attached).
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`Please note that the final printed labeling included with your additional supplemental application
`(NDA 21-866 / S-002) submitted on November 3, 2006 (amended on November 17, 2006) has been
`superseded by these applications. Although it will not be reviewed, it will be retained in our files.
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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 the requirements for an approved NDA set forth under
`21 CFR 314.80 and 314.81.
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`NDA 21-436 / S-016
`NDA 21-713 / S-010
`NDA 21-729 / S-002
`NDA 21-866 / S-003 / S-002
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`Page 2
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`If you have any questions, email CAPT Steven D. Hardeman, R.Ph., Chief, Project Management Staff
`at Steven.Hardeman@FDA.HHS.GOV.
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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/
`---------------------
`Thomas Laughren
`9/25/2007 03:30:43 PM
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