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FDA BLA · BLA761180

ADBRY

tralokinumab-ldrm

Sponsor: LEO PHARMA AS

APPLICATION
BLA761180
TYPE
BLA
ORIGINAL APPROVAL
2021-12-27
LATEST ACTION
2025-12-17
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ADBRYPrescription
TRALOKINUMAB 150MG/ML · INJECTABLE · INJECTION

Approval history

2025-12-17Type 1 - New Molecular Entity · Supplement 20 · standardAP
2025-12-12Labeling · Supplement 19 · standard — Letter ↗AP
2024-06-12Efficacy · Supplement 6 · standard — Label ↗AP
2023-12-14Efficacy · Supplement 1 · standard — Label ↗AP
2023-06-02Labeling · Supplement 5 · standard — Letter ↗AP
2022-07-27Labeling · Supplement 2 · standard — Letter ↗AP
2021-12-27Type 1 - New Molecular Entity · 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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