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FDA BLA · BLA761043

BENLYSTA

belimumab

Sponsor: GLAXOSMITHKLINE LLC

APPLICATION
BLA761043
TYPE
BLA
ORIGINAL APPROVAL
2017-07-20
LATEST ACTION
2025-06-20
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BENLYSTAPrescription
BELIMUMAB 200MG/ML · INJECTABLE · INJECTION

Approval history

2025-06-20Efficacy · Supplement 34 · standard — Label ↗AP
2024-05-16Efficacy · Supplement 27 · standard — Label ↗AP
2024-02-09Labeling · Supplement 28 · standard — Label ↗AP
2023-02-15Efficacy · Supplement 22 · standard — Letter ↗AP
2022-07-26Labeling · Supplement 21 · standard — Letter ↗AP
2020-12-16Efficacy · Supplement 13 · priority — Label ↗AP
2020-01-17Labeling · Supplement 8 · standard — Label ↗AP
2019-09-13Labeling · Supplement 5 · standard — Label ↗AP
2019-04-26Labeling · Supplement 7 · standard — Letter ↗AP
2018-06-22Labeling · Supplement 2 · standard — Letter ↗AP
2017-07-20Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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