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` NDA 208082/S-007
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`SUPPLEMENT APPROVAL
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` Teva Branded Pharmaceutical Products R&D, Inc.
` Attention: Angela Randall, Director
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` Regulatory Affairs Labeling
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` 145 Brandywine Parkway
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` West Chester, PA 19380
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` Dear Ms. Randall:
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` Please refer to your supplemental new drug application (sNDA) dated June 17, 2020,
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` received June 17, 2020, and your amendments, submitted pursuant to section 505(b)(2)
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` of 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 in
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` Section 2.1 (Dosing Information), Section 5.3 (QTc Prolongation), Section 7.2 (Drugs
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` that Cause QTc Prolongation), Section 12.2 (Pharmacodynamics), and the Medication
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` Guide.
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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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`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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` 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: 4709843
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` NDA 208082/S-007
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` Page 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
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` 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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` 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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`Eric Bastings, MD
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`Director (acting)
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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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`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: 4709843
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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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`ERIC P BASTINGS
`12/02/2020 08:01:57 AM
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`Reference ID: 4709843
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