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` NDA APPROVAL
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`... -... II
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`U.S. FOOD & DRUG
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`ADMINISTRATION
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` NDA 216354
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`Teva Neuroscience, Inc.
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`Attention: Randy Thear, MBA
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`Associate Director, Global Regulatory Affairs
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`145 Brandywine Parkway
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`West Chester, PA 19380
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`Dear Mr. Thear:
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`Please refer to your new drug application (NDA) dated April 21, 2022, received April 21,
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`2022, and your amendments, submitted pursuant to section 505(b)(2) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for Austedo XR (deutetrabenazine extended-
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`release) 6, 12, and 24 mg tablets.
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`This NDA provides for the use of Austedo XR (deutetrabenazine extended-release)
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`6, 12, and 24 mg tablets for the treatment of chorea associated with Huntington’s
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`disease and tardive dyskinesia.
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
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`labeling.
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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
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information and Medication Guide) as well as annual reportable changes
`not included in the enclosed labeling. Information on submitting SPL files using eLIST
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`may be found in the guidance for industry SPL Standard for Content of Labeling
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`Technical Qs and As.2
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`The SPL will be accessible via publicly available labeling repositories.
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`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`Reference ID: 5128727
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` NDA 216354
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`Page 2
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`CARTON AND CONTAINER LABELING
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`Submit final printed carton and container labeling that are identical to the clean versions
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`of carton and container labeling submitted on February 15, 2023, as soon as they are
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`available, but no more than 30 days after they are printed. Please submit these labeling
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`electronically according to the guidance for industry SPL Standard for Content of
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`Labeling Technical Qs & As. For administrative purposes, designate this submission
`“Final Printed Carton and Container Labeling for approved NDA 216354.” Approval
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`of this submission by FDA is not required before the labeling is used.
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` DATING PERIOD
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`Based on the stability data submitted to date, the expiry dating period for Austedo XR
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`(deutetrabenazine extended-release) 6, 12, and 24 mg tablets shall be as stated below
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`based on the dosage strength and packaging types when stored at controlled room
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`temperature, 20°C to 25°C:
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`• 6 mg tablets in 30-count bottles: 18 months
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`• 12 mg and 24 mg tablets in 30-count bottles: 24 months
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`• 6 mg, 12 mg, and 24 mg tablets in blister packs: 18 months
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`Results of ongoing stability should be submitted throughout the dating period in your
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`annual report, as they become available, including the results of stability studies from
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`the first three production lots of each strength and primary container.
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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
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`• Because deutetrabenazine (Austedo, SD-809/TEV 50717) has been granted
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`orphan drug designation for the treatment of chorea associated with Huntington’s
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`disease, you are exempt from this requirement for this indication.
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`• For the treatment of tardive dyskinesia, we are waiving the pediatric study
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`requirement for this application because the necessary studies are impossible or
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`highly impracticable because the because the condition is rare in pediatric
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`patients.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 5128727
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` NDA 216354
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`Page 3
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format—Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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` As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials,
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` and the Prescribing Information, at the time of initial dissemination or publication,
` accompanied by a Form FDA 2253. Form FDA 2253 is available at FDA.gov.4
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`Information and Instructions for completing the form can be found at FDA.gov.5
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, please contact Stacy Metz, PharmD, Senior Regulatory
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`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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`Teresa Buracchio, MD
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`Director
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`Division of Neurology 1
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`Office of Neuroscience
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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`o Medication Guide
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`3 For the most recent version of a guidance, check the FDA guidance web page at
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`https://www.fda.gov/media/128163/download.
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`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 5128727
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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
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`/s/
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`TERESA J BURACCHIO
`02/17/2023 12:43:56 PM
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`Reference ID: 5128727
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