`
`NDA 21436/S-36
`NDA 21713/S-28
`NDA 21729/S-20
`NDA 21866/S-21
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL/
`FULFILLMENT OF POSTMARKETING
`
`REQUIREMENT
`
`Otsuka Pharmaceutical Development & Commercialization, Inc.
`Attention: David Goldberger, RPh, RAC
`Vice President, Global Regulatory Affairs
`2440 Research Blvd.
`Rockville, MD 20850
`
`Dear Mr. Goldberger:
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated and received March
`
`15, 2013, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for Abilify (aripiprazole) tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg (NDA 21436), oral
`
`solution 1 mg/ml (NDA 21713), orally disintegrating tablet 10 mg, 15 mg (NDA 21729), and
`injectable formulation 9.75 mg/1.3 mL single-dose vial (NDA 21866).
`
`We acknowledge receipt of your amendment dated May 13, 2014.
`
`The May 13, 2014, submission constituted a complete response to our March 24, 2014, action
`letter.
`
`These “Prior Approval” supplemental new applications propose labeling revisions resulting from
`
`clinical trial CN138603, a maintenance trial in pediatric patients with irritability associated with
`
`autistic disorder. The study was conducted as a postmarketing requirement (#1570-1) as
`requested in our Agency letter dated November 19, 2009.
`
`
`We have completed our review of these supplemental applications. They are approved, effective
`on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert and Medication
`
`Reference ID: 3520410
`
`
`
`NDA 21436/S-36, 21713/S-28, 21729/S-20, 21866/S-21
`Page 2
`
`Guide), with the addition of any labeling changes in pending “Changes Being Effected” (CBE)
`supplements, as well as annual reportable changes not included in the enclosed labeling.
`
`
`Information on submitting SPL files using eList may be found in the guidance for industry titled
`
`
`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`
`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
`
`should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
`
`FULFILLMENT OF POSTMARKETING REQUIREMENT
`
`
`We have received your submission dated March 15, 2013, containing the final report for the
`following postmarketing requirement listed in the November 19, 2009 letter.
`
`
`1570-1
`
`A deferred pediatric study under PREA for a maintenance treatment study to
`
`obtain long-term efficacy and safety data in patients ages 6-16 years.
`
`
`We have reviewed your submission and conclude that the above requirement was fulfilled.
`
`This completes all of your postmarketing requirements and postmarketing commitments
`
`
`acknowledged in our November 19, 2009, letter.
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`
`
`
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`
`
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
`
`Reference ID: 3520410
`
`
`
`NDA 21436/S-36, 21713/S-28, 21729/S-20, 21866/S-21
`Page 3
`
` You must submit final promotional materials and package insert(s), accompanied by a Form
`
`
`
`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
`FDA 2253 is available at
`
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`
`
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`REPORTING REQUIREMENTS
`
`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, email Simran Parihar, Pharm.D., Regulatory Health Project Manager,
`
`at simran.parihar@fda.hhs.gov.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Mitchell V. Mathis, M.D.
`CAPT, USPHS
`Director
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`ENCLOSURE:
`Content of Labeling
`
`Reference ID: 3520410
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MITCHELL V Mathis
`06/09/2014
`
`Reference ID: 3520410
`
`