← FDA DRUG APPROVALS

FDA NDA · NDA022253

VIMPAT

lacosamide

Sponsor: UCB INC

APPLICATION
NDA022253
TYPE
NDA
ORIGINAL APPROVAL
2008-10-28
LATEST ACTION
2023-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VIMPAT · ReferencePrescription
LACOSAMIDE 200MG · TABLET · ORAL
VIMPAT · ReferencePrescription
LACOSAMIDE 100MG · TABLET · ORAL
VIMPAT · ReferencePrescription
LACOSAMIDE 150MG · TABLET · ORAL
VIMPAT · ReferencePrescription
LACOSAMIDE 50MG · TABLET · ORAL

Approval history

2023-10-16Labeling · Supplement 57 · standard — Letter ↗AP
2023-04-28Efficacy · Supplement 50 · standard — Letter ↗AP
2022-09-30Labeling · Supplement 55 · standard — Letter ↗AP
2022-05-19Labeling · Supplement 54 · standard — Label ↗AP
2021-10-14Efficacy · Supplement 49 · standard — Label ↗AP
2021-09-20Manufacturing (CMC) · Supplement 53AP
2021-09-15Labeling · Supplement 51 · standard — Letter ↗AP
2020-11-16Efficacy · Supplement 48 · standard — Label ↗AP
2020-11-16Efficacy · Supplement 46 · standard — Label ↗AP
2019-06-11Labeling · Supplement 45 · standard — Label ↗AP
2019-01-09Efficacy · Supplement 41 · standard — Label ↗AP
2018-11-11Labeling · Supplement 42 · standard — Label ↗AP
2017-11-03Efficacy · Supplement 39 · standard — Label ↗AP
2017-03-24Labeling · Supplement 37 · standard — Label ↗AP
2017-01-06Manufacturing (CMC) · Supplement 35 · standardAP
2016-05-27Manufacturing (CMC) · Supplement 33 · standardAP
2016-05-05Manufacturing (CMC) · Supplement 32 · standardAP
2015-07-09Labeling · Supplement 30 · standard — Letter ↗AP
2015-04-15Manufacturing (CMC) · Supplement 31 · standardAP
2014-08-29Efficacy · Supplement 26 · standard — Label ↗AP
2014-08-29Efficacy · Supplement 27 · standard — Label ↗AP
2014-08-12Labeling · Supplement 28 · standard — Label ↗AP
2014-06-04Manufacturing (CMC) · Supplement 29 · standardAP
2014-01-16Labeling · Supplement 23 · unknown — Label ↗AP
2013-10-11Manufacturing (CMC) · Supplement 25 · standardAP
2013-09-25Labeling · Supplement 16 · unknown — Label ↗AP
2013-09-25Labeling · Supplement 14 · standard — Label ↗AP
2013-04-17Labeling · Supplement 24 · standard — Label ↗AP
2013-02-08Labeling · Supplement 10 · standard — Label ↗AP
2013-02-05Labeling · Supplement 21 · standard — Label ↗AP
2012-12-03Manufacturing (CMC) · Supplement 22 · standardAP
2011-08-10REMS · Supplement 20 — Letter ↗AP
2010-04-20Labeling · Supplement 6 · unknown — Letter ↗AP
2009-11-18Labeling · Supplement 4 · standard — Label ↗AP
2008-10-28Type 1 - New Molecular Entity · Original · standard — Summary Review ↗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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