← FDA DRUG APPROVALS

FDA NDA · NDA020427

SABRIL

vigabatrin

Sponsor: LUNDBECK PHARMS LLC

APPLICATION
NDA020427
TYPE
NDA
ORIGINAL APPROVAL
2009-08-21
LATEST ACTION
2026-03-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SABRIL · ReferencePrescription
VIGABATRIN 500MG · TABLET · ORAL

Approval history

2026-03-18REMS · Supplement 29 — Letter ↗AP
2024-09-12REMS · Supplement 27 — Letter ↗AP
2022-10-12REMS · Supplement 26 — Letter ↗AP
2021-10-20Labeling · Supplement 25 · standard — Label ↗AP
2020-10-20Labeling · Supplement 23 · standard — Letter ↗AP
2020-10-02REMS · Supplement 24 — Letter ↗AP
2020-01-24Efficacy · Supplement 21 · standard — Letter ↗AP
2019-09-12REMS · Supplement 22 — Letter ↗AP
2019-07-31Labeling · Supplement 20 · standard — Letter ↗AP
2019-05-31REMS · Supplement 19 — Letter ↗AP
2018-08-21Labeling · Supplement 18 · standard — Label ↗AP
2017-10-23REMS · Supplement 17 — Letter ↗AP
2017-04-27Labeling · Supplement 16 · standard — Letter ↗AP
2016-06-21REMS · Supplement 14 — Label ↗AP
2015-09-18Labeling · Supplement 15 · standard — Letter ↗AP
2014-04-03Labeling · Supplement 13 · standard — Letter ↗AP
2013-10-26Efficacy · Supplement 11 · priority — Letter ↗AP
2013-10-26Labeling · Supplement 12 · priority — Label ↗AP
2013-10-26Labeling · Supplement 10 · standard — Label ↗AP
2012-12-14Manufacturing (CMC) · Supplement 8 · standardAP
2012-12-11Labeling · Supplement 5 · unknown — Letter ↗AP
2011-01-18Labeling · Supplement 2 · unknown — Letter ↗AP
2009-08-21Type 1 - New Molecular Entity · Original · standard — 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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