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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 208082
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`Food and Drug Administration
`Silver Spring MD 20993
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`NDA APPROVAL
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`Teva Pharmaceuticals, Inc.
`Attention: Christine Schulteis, PhD
`Global Regulatory Affairs
`3333 North Torrey Pines Court
`Suite 400
`La Jolla, CA 92037
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`Dear Dr. Schulteis:
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`Please refer to your New Drug Application (NDA) dated May 29, 2015, received May 29, 2015,
`and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
`Cosmetic Act for Austedo (deutetrabenazine) 6 mg, 9 mg, and 12 mg Tablets.
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`We acknowledge receipt of your amendment dated October 3, 2016, which constituted a
`complete response to our May 27, 2016, action letter.
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`This new drug application provides for the use of Austedo (deutetrabenazine) Tablets for the
`treatment of chorea associated with Huntington’s disease.
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`We have completed our review of this application, as amended. 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). Information on submitting SPL files using eLIST may be found in the guidance for
`industry SPL Standard for Content of Labeling Technical Qs and As, available at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
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`The SPL will be accessible via publicly available labeling repositories.
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`Reference ID: 4078379
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`NDA 208082
`Page 2
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and immediate container labels that are identical to the carton and
`immediate container labels submitted on March 30, 2017, as soon as they are available, but no
`more than 30 days after they are printed. Please submit these labels electronically according to
`the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain
`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications (May 2015, Revision 3). Alternatively, you may submit 12 paper copies, with 6 of
`the copies individually mounted on heavy-weight paper or similar material. For administrative
`purposes, designate this submission “Final Printed Carton and Container Labels for
`approved NDA 208082.” Approval of this submission by FDA is not required before the
`labeling is used.
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`ADVISORY COMMITTEE
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`Your application for Austedo (deutetrabenazine) was not referred to an FDA advisory committee
`because outside expertise was not necessary; there were no controversial issues that would
`benefit from advisory committee discussion.
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
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`Because this drug product for this indication has an orphan drug designation, you are exempt
`from this requirement.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert,
`Medication Guide, and patient PI (as applicable) to:
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`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`Reference ID: 4078379
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`NDA 208082
`Page 3
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
`For more information about submitting promotional materials in eCTD format, see the draft
`Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
`UCM443702.pdf ).
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
`2253. 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.
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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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`MEDWATCH-TO-MANUFACTURER PROGRAM
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`The MedWatch-to-Manufacturer Program provides manufacturers with copies of serious adverse
`event reports that are received directly by the FDA. New molecular entities and important new
`biologics qualify for inclusion for three years after approval. Your firm is eligible to receive
`copies of reports for this product. To participate in the program, please see the enrollment
`instructions and program description details at
`http://www.fda.gov/Safety/MedWatch/HowToReport/ucm166910.htm.
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`POST APPROVAL FEEDBACK MEETING
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`New molecular entities and new biologics qualify for a post approval feedback meeting. Such
`meetings are used to discuss the quality of the application and to evaluate the communication
`process during drug development and marketing application review. The purpose is to learn
`from successful aspects of the review process and to identify areas that could benefit from
`improvement. If you would like to have such a meeting with us, call the Regulatory Project
`Manager for this application.
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`Reference ID: 4078379
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`NDA 208082
`Page 4
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`If you have any questions, call Stacy Metz, PharmD, Regulatory Project Manager, at (301) 796-
`2139.
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`Sincerely,
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`{See appended electronic signature page}
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`Ellis F. Unger, MD
`Director
`Office of Drug Evaluation I
`Office of New Drugs
`Center for Drug Evaluation and Research
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`Enclosure(s):
`Content of Labeling
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`Reference ID: 4078379
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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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`ELLIS F UNGER
`04/03/2017
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`Reference ID: 4078379
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`(
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