← FDA DRUG APPROVALS

FDA BLA · BLA125370

BENLYSTA

belimumab

Sponsor: HUMAN GENOME SCIENCES INC.

APPLICATION
BLA125370
TYPE
BLA
ORIGINAL APPROVAL
2011-03-09
LATEST ACTION
2025-06-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BENLYSTAPrescription
BELIMUMAB 400MG · INJECTABLE · INJECTION
BENLYSTAPrescription
BELIMUMAB 120MG · INJECTABLE · INJECTION

Approval history

2025-06-20Labeling · Supplement 85 · standard — Label ↗AP
2024-05-16Labeling · Supplement 81 · standard — Label ↗AP
2024-02-09Labeling · Supplement 82 · standard — Label ↗AP
2023-02-15Labeling · Supplement 79 · standard — Letter ↗AP
2022-07-26Efficacy · Supplement 78 · priority — Letter ↗AP
2020-12-16Efficacy · Supplement 73 · priority — Label ↗AP
2020-09-24Efficacy · Supplement 71 · standard — Letter ↗AP
2020-01-17Efficacy · Supplement 68 · standard — Label ↗AP
2019-09-13Labeling · Supplement 67 · standard — Label ↗AP
2019-04-26Efficacy · Supplement 64 · priority — Letter ↗AP
2018-06-22Labeling · Supplement 62 · standard — Letter ↗AP
2017-01-18Labeling · Supplement 57 · standard — Label ↗AP
2016-12-02Labeling · Supplement 55 · standard — Label ↗AP
2014-04-03Labeling · Supplement 53 · standard — Label ↗AP
2013-12-13Labeling · Supplement 47 · standard — Label ↗AP
2012-03-30Labeling · Supplement 16 · standard — Letter ↗AP
2011-03-09Type 1 - New Molecular Entity · Original · priority — 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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