`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`NDA 21436 / S-037
`NDA 21866 / S-022
`NDA 21713 / S-029
`NDA 21729 / S-021
`
`
`
`
`
`
`
`Food and Drug Administration
`
`Silver Spring MD 20993
`
`
`SUPPLEMENT APPROVAL
`
`
`
`Otsuka Pharmaceutical Development & Commercialization, Inc.
`Attention: David Goldberger, R.Ph., 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 May 8,
`2013, submitted under section 505(b) of the Federal Food Drug, and Cosmetic Act (FDCA) for
`Abilify (aripiprazole) tablets, oral solution, orally disintegrating tablets, and injectable
`formulation.
`
`These “Prior Approval” supplemental new drug applications provide for revisions to the Nursing
`Mothers section of labeling and the Medication Guide.
`
`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, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling (text for the package insert and Medication Guide) and include
`the labeling changes proposed in any pending “Changes Being Effected” (CBE) supplements.
`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.
`
`
`Reference ID: 3348855
`
`
`
`NDA 21436 / S-037
`NDA 21866 / S-022
`NDA 21713 / S-029
`NDA 21729 / S-021
`Page 2
`
`
`Also within 14 days, amend all pending supplemental applications for this NDA, including
`pending 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.
`
`LETTERS TO HEALTH CARE PROFESSIONALS
`
`
`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA to the following
`address:
`
`MedWatch Program
`Office of Special Health Issues
`
`Food and Drug Administration
`10903 New Hampshire Ave
`Building 32, Mail Stop 5353
`
`Silver Spring, MD 20993
`
`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, call Sonny Saini, Pharm.D., MBA, Regulatory Project Manager, at
`(301) 796-0532.
`
`
`
`
`
`
`
`ENCLOSURE:
`Content of Labeling
`
`
`
`
`Reference ID: 3348855
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Mitchell V. Mathis, M.D.
`CAPT, USPHS
`Director (acting)
`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`
`
`---------------------------------------------------------------------------------------------------------
`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
`07/30/2013
`
`Reference ID: 3348855
`
`