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FDA BLA · BLA761032

SILIQ

brodalumab

Sponsor: VALEANT LUXEMBOURG

APPLICATION
BLA761032
TYPE
BLA
ORIGINAL APPROVAL
2017-02-15
LATEST ACTION
2026-05-07
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SILIQPrescription
BRODALUMAB 210MG/1.5ML · INJECTABLE · INJECTION

Approval history

2026-05-07REMS · Supplement 21 — Letter ↗AP
2026-02-27REMS · Supplement 20 — Letter ↗AP
2024-08-12Labeling · Supplement 14 · standard — Label ↗AP
2024-07-02Labeling · Supplement 16 · standard — Letter ↗AP
2023-07-19REMS · Supplement 11 — Letter ↗AP
2022-06-14REMS · Supplement 10 — Letter ↗AP
2021-01-22REMS · Supplement 8 — Letter ↗AP
2018-10-09REMS · Supplement 5 — Letter ↗AP
2018-01-26REMS · Supplement 4 — Letter ↗AP
2017-06-08REMS · Supplement 1 — Letter ↗AP
2017-02-15Type 1 - New Molecular Entity · 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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