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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 208082/S-002
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Teva Branded Pharmaceutical Products R&D, Inc.
`Attention: David Truong, PharmD, MS
`Associate Director, Regulatory Affairs
`41 Moores Road
`Frazer, PA 19355
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`Dear Dr. Truong:
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`Please refer to your Supplemental New Drug Application (sNDA) dated December 6, 2017,
`received December 6, 2017, submitted pursuant to section 505(b)(2) of the Federal Food, Drug,
`and Cosmetic Act (FDCA) for Austedo (deutetrabenazine) 6 mg, 9 mg, and 12 mg Tablets.
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`This “Changes Being Effected” supplemental new drug application provides for an update to
`NDA 208082, approved April 3, 2017, for treatment of chorea associated with
`Huntington’s disease, with the Austedo Prescribing Information approved by the Division of
`Psychiatry Products for NDA 209885 on August 30, 2017, for treatment of tardive dyskinesia.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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`CONTENT OF LABELING
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`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
`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.
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`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.
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`The SPL will be accessible from publicly available labeling repositories.
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`Reference ID: 4273761
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`NDA 208082/S-002
`Page 2
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`Also within 14 days, amend all pending supplemental applications that include 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).
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`REPORTING REQUIREMENTS
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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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`If you have any questions, please contact Stacy Metz, PharmD, Senior Regulatory Project
`Manager, at stacy.metz@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Billy Dunn, MD
`Director
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
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`Reference ID: 4273761
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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/
`------------------------------------------------------------
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`WILLIAM H Dunn
`06/06/2018
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`Reference ID: 4273761
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`(
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