`NDA 204063/S-26
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`SUPPLEMENT APPROVAL
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` Biogen, Inc.
` Attention: Priya Singhal, MD, MPH
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` Senior Vice President
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` Global Safety and Regulatory Science
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` 225 Binney Street
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` Cambridge, MA 02142
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` Dear Dr. Singhal:
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` Please refer to your supplemental new drug application (sNDA) dated and received
` August 5, 2020, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and
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` Cosmetic Act (FDCA) for Tecfidera (dimethyl fumarate) delayed-release capsules.
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` This Prior Approval supplemental new drug application provides for the addition or
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` rhinorrhea to Section 6.2 (Adverse Reactions; Postmarketing Experience) of the
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` APPROVAL & LABELING
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`We have completed our review of this application. It is approved, effective on the date of
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`this letter, for use as recommended in the enclosed agreed-upon 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 Patient Package Insert), 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
` 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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` 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: 4738800
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` NDA 204063/S-26
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` Page 2
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` Also within 14 days, amend all pending supplemental applications that include labeling
` 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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` PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. For information about submitting promotional materials, see the
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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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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`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 call Sandra Folkendt, Senior Regulatory Health
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`Project Manager, at (240) 402-2804.
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`Sincerely,
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`{See appended electronic signature page}
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`Alice T.D. Hughes, MD
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`Deputy Director for Safety
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`Division of Neurology 2
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`Office of Neuroscience
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`Center for Drug Evaluation and Research
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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
`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: 4738800
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`NDA 204063/S-26
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`Page 3
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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 Patient Package Insert
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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: 4738800
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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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`ALICE HUGHES
`01/29/2021 01:55:47 PM
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`Reference ID: 4738800
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