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` DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` Food and Drug Administration
` Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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` NDA 204063/S-009
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`Biogen Idec
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`Attention: Nadine D. Cohen, Ph.D.
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`Senior Vice President, Regulatory Affairs
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`14 Cambridge Center
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`Cambridge, MA 02142
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`Dear Dr. Cohen:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received October
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`14, 2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
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`for Tecfidera (dimethyl fumarate) Tablets, 120 mg and 240 mg .
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`This “Prior Approval” supplemental new drug application provides for Biogen’s response to the
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`Agency’s recommendations made during a previous postmarketing review for revised container
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`labels for Tecfidera 30-day Starter Pack.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is approved, effective on the
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`date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and immediate container labels that are identical to the enclosed
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`carton and immediate container labels as soon as they are available, but no more than 30 days
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`after they are printed. Please submit these labels electronically according to the guidance for
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`industry Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical
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`Product Applications and Related Submissions Using the eCTD Specifications (June 2008).
`Alternatively, you may submit 12 paper copies, with 6 of the copies individually mounted on
`heavy-weight paper or similar material. For administrative purposes, designate this submission
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`“Final Printed Carton and Container Labels for approved NDA 204063/S-009. Approval of this
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`submission by FDA is not required before the labeling is used.
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`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
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`the product misbranded and an unapproved new drug.
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`Reference ID: 3658403
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` NDA 204063/S-009
` Page 2
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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, contact Laurie Kelley, PA-C, Regulatory Project Manager, via
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`telephone at (301) 796-5068 or via email at Laurie.Kelley@fda.hhs.gov.
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` Sincerely,
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`{See appended electronic signature page}
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`Eric Bastings, M.D.
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`Deputy Director
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`Division of Neurology Products
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`Office of Drug Evaluation I
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`Carton and Container Labeling
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`Reference ID: 3658403
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`ERIC P BASTINGS
`11/14/2014
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`Reference ID: 3658403
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