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FDA NDA · NDA211855

VUMERITY

diroximel fumarate

Sponsor: BIOGEN

APPLICATION
NDA211855
TYPE
NDA
ORIGINAL APPROVAL
2019-10-29
LATEST ACTION
2024-09-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

VUMERITY · ReferencePrescription
DIROXIMEL FUMARATE 231MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-09-11Manufacturing (CMC) · Supplement 17 · standard — Label ↗AP
2024-03-22Labeling · Supplement 15 · standard — Label ↗AP
2023-12-13Labeling · Supplement 16 · standard — Letter ↗AP
2023-02-10Efficacy · Supplement 9 · standard — Letter ↗AP
2022-11-16Manufacturing (CMC) · Supplement 11 — Letter ↗AP
2022-09-29Labeling · Supplement 10 · standard — Letter ↗AP
2022-02-10Labeling · Supplement 6 · standard — Label ↗AP
2021-01-29Labeling · Supplement 4 · standard — Label ↗AP
2020-08-21Labeling · Supplement 2 · standard — Letter ↗AP
2019-10-29Type 2 - New Active Ingredient · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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