An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 211855
Company: BIOGEN INC

Products on NDA 211855

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VUMERITY	DIROXIMEL FUMARATE	231MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211855

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2019	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211855s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211855Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211855Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211855s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211855Orig1s016ltr.pdf
03/22/2024	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211855s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211855Orig1s015ltr.pdf
11/16/2022	SUPPL-11	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211855Orig1s011ltr.pdf
09/29/2022	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211855Orig1s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211855s010lbl.pdf
02/10/2023	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211855s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211855Orig1s009ltr.pdf
02/10/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211855Orig1s006ltr.pdf
01/29/2021	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211855s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211855Orig1s004ltr.pdf
08/21/2020	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211855s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211855Orig1s002ltr.pdf

Labels for NDA 211855

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/22/2024	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211855s015lbl.pdf
12/13/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211855s016lbl.pdf
02/10/2023	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211855s009lbl.pdf
11/16/2022	SUPPL-11	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855Orig1s011lbl.pdf
09/29/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855s010lbl.pdf
02/10/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855s006lbl.pdf
01/29/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211855s004lbl.pdf
08/21/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211855s002lbl.pdf
08/21/2020	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211855s002lbl.pdf
10/29/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211855s000lbl.pdf

Top