`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDAs 21-436/S-023, 21-713/S-018, 21-729/S-010, 21-866/S-010
`
`Susan H. Behling
`Director, Global Regulatory Strategy
`Bristol-Myers Squibb Company
`P.O. Box 5100
`Wallingford, CT 06492-7660
`
`
`Dear Ms. Behling:
`
`We acknowledge receipt of your supplemental new drug applications submitted under section 505(b)
`of the Federal Food, Drug, and Cosmetic Act for Abilify (aripiprazole) tablets, Abilify Discmelt
`(aripiprazole) orally disintegrating tablets, Abilify (aripiprazole) oral solution, and Abilify
`(aripiprazole) injection dated February 13, 2008.
`
`We additionally refer to e-mail communications from the Agency dated January 16, 2008 and January
`23, 2008, requesting revisions to your prescriber labeling.
`
`These new drug applications, submitted under “Changes Being Effected” provide for the following
`revisions to the Adverse Reactions-Extrapyramidal Symptoms-Dystonia section of labeling:
`
`
`
`ADVERSE REACTIONS
`
`6.2
`
`Clinical Studies Experience
`
` 6
`
` Dystonia
`
`Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may
`occur in susceptible individuals during the first few days of treatment. Dystonic symptoms
`include: spasm of the neck muscles, sometimes progressing to tightness of the throat,
`swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these
`symptoms can occur at low doses, they occur more frequently and with greater severity with
`high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of
`acute dystonia is observed in males and younger age groups.
`
`
`We note that you have incorporated our changes, verbatim, as requested in the aforementioned Agency
`communications.
`
`We have completed our review of these applications, and they are approved, effective on the date of
`this letter.
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`
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`NDAs 21-436/S-023, 21-713/S-018, 21-729/S-010, 21-866/S-010
`Page 2
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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 supplements NDAs 21-436/S-023, 21-713/S-018, 21-729/S-010,
`21-866/S-010.” We expect that your February 13, 2008 labeling will be updated when submitted in
`SPL format to incorporate the revisions in the Agency approval letter dated February 27, 2008.
`
`We expect that the revised labeling would be available on your website within 10 days of receipt of
`this letter and that it would accompany any newly shipped product in a reasonable amount of time.
`Drug product already in distribution with currently approved labeling may remain in distribution.
`
`Failure to make these changes within the specified period of time could make your product misbranded
`under 21 USC 321(n) and 352(a).
`
`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:
`
`
`
`
`
`
`
`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 Sonny Saini, Pharm. D., Safety Regulatory Project Manager, at
`(301) 796-0532.
`
`
`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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`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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`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Mitchell Mathis
`3/6/2008 03:06:12 PM
`For Dr. Laughren
`
`
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