`
`
`
` NDA 204063/S-24
`
`Biogen, Inc.
`Attention: Trevor Mill
`Senior Vice President,
`Global Safety and Regulatory Sciences
`
`225 Binney Street
`Cambridge, MA 02142
`
`Dear Mr. Mill:
`
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`April 30, 2019, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act (FDCA) for Tecfidera (dimethyl fumarate) 120 mg and 240 mg capsules.
`
`
`This Prior Approval sBLA provides for an updated Indications and Usage statement as
`requested in the Prior Approval Supplement Request letter dated April 12, 2019 .
`Approval & Labeling
`
`We have completed our review of this application. It is approved, effective on the date of
`this letter, for use as recommended in the enclosed agreed-upon labeling.
`
`
`Content Of Labeling
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information, Patient Package Insert, and Instructions for Use), with the
`addition of any labeling changes in pending “Changes Being Effected” (CBE)
`supplements, as well as annual reportable changes not included in the enclosed
`
`labeling.
`
`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
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance Documents Database
`https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`Reference ID: 4460139
`
`
`
`NDA 204063/S-24
`Page 2
`
`
`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
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
`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
`supplement number(s) and annual report date(s).
`
`Required Pediatric Assessments
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`new active ingredients (which includes new salts and new fixed combinations), new
`indications, new dosage forms, new dosing regimens, or new routes of administration
`are required to contain an assessment of the safety and effectiveness of the product for
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`Because none of these criteria apply to your application, you are exempt from this
`requirement.
`
`Reporting Requirements
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, please call Sandra Folkendt, Regulatory Project Manager, at
`
`
`(240) 402-2804.
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Nick Kozauer, MD
`
`Deputy Director (Acting)
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE(S):
` Content of Labeling
`
`o Prescribing Information
`
`o Patient Package Insert
`
`o
`Instructions for Use
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4460139
`
`
`
`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.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`NICHOLAS A KOZAUER
`07/10/2019 12:32:55 PM
`
`Reference ID: 4460139
`
`(
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