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` NDA 208082/S-008
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`SUPPLEMENT APPROVAL
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`Teva Branded Pharmaceutical Products R&D, Inc.
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`Attention: Angela Randall
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`Director, 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 and received
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`August 13, 2020, and your amendments, pursuant to section 505(b)(2) of the Federal
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`Food, Drug, and Cosmetic Act (FDCA) for Austedo (deutetrabenazine) Tablets, 6
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`mg, 9 mg, and 12 mg.
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`This Prior Approval supplemental new drug application provides for addition of a new
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`physician sample package configuration that expands the currently approved 2-week
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`titration pack to include a 4-week titration kit.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is
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`approved, effective on the date of this letter, for use as recommended in the enclosed
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`agreed-upon labeling.
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`CARTON AND CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to enclosed carton and
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`container labels, 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
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`Providing Regulatory Submissions in Electronic Format – Certain Human
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`Pharmaceutical Product Applications and Related Submissions Using the eCTD
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`Specifications. For administrative purposes, designate this submission “Product
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`Correspondence – Final Printed Carton and Container Labels for approved NDA
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`208082/S-008.” Approval of this submission by FDA is not required before the labeling
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`is used.
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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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` U.S. Food & Drug Administration
` Silver Spring, MD 20993
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` www.fda.gov
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`NDA 208082/S-008
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`Page 2
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`If you have any questions, call Avani Patel, Regulatory Business Process Manager, at
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`(240) 402 - 1845.
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`Sincerely,
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`{See appended electronic signature page}
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`David Lewis, Ph.D.
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`Branch Chief, Branch 2
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`Division of Post-Marketing Activities I
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`Office of Lifecycle Drug Products
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`Office of Pharmaceutical Quality
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`Center for Drug Evaluation and Research
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`Enclosures:
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`Carton and Container Labeling
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` U.S. Food & Drug Administration
` Silver Spring, MD 20993
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` www.fda.gov
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`

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`David
`Lewis
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`Digitally signed by David Lewis
`Date: 2/09/2021 09:17:52AM
`GUID: 508da72000029f287fa31e664741b577
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`(
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