`NDA 208082/S-009
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`SUPPLEMENT APPROVAL
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` Teva Branded Pharmaceutical Products R&D, Inc.
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` Attention: Xuan-Tien Huynh, MS
` Sr. Manager, Global Regulatory Affairs
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` 145 Brandywine Parkway
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` West Chester, PA 19380
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`Dear Ms. Huynh:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`December 28, 2020, and your amendments, submitted pursuant to section 505(b)(2) of
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`the Federal Food, Drug, and Cosmetic Act (FDCA) for Austedo (deutetrabenazine) 6
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`mg, 9 mg, and 12 mg Tablets.
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`This Prior Approval supplemental new drug application provides for labeling changes to
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`section 8.4 (Pediatric Use), obtained from studies completed in response to our Written
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`Request issued January 8, 2020, regarding the use of deutetrabenazine in patients age
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`6 to 16 for the treatment of Tourette Syndrome. These changes include description of
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`studies conducted, relevant safety information, and description of juvenile animal
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`toxicity data.
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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), with the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`reportable changes not included in the enclosed labeling.
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 4816500
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` NDA 208082/S-009
` Page 2
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that include labeling
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
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`annual reportable changes. To facilitate review of your submission(s), provide a
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`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
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`supplement number(s) and annual report date(s).
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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 none of these criteria apply to your application, you are exempt from this
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`requirement.
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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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` 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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`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: 4816500
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`NDA 208082/S-009
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`Page 3
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`If you have any questions, email Valerie Magda, Regulatory Project Manager, at
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`Valerie.Magda@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`Tiffany R. Farchione, MD
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`Director
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`Division of Psychiatry
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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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`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: 4816500
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`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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`BERNARD A FISCHER on behalf of TIFFANY R FARCHIONE
`06/24/2021 03:25:06 PM
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`Reference ID: 4816500
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`(
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