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FDA BLA · BLA761070

FASENRA

benralizumab

Sponsor: ASTRAZENECA AB

APPLICATION
BLA761070
TYPE
BLA
ORIGINAL APPROVAL
2017-11-14
LATEST ACTION
2026-05-13
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FASENRAPrescription
BENRALIZUMAB 30MG/ML · INJECTABLE · INJECTION

Approval history

2026-05-13Efficacy · Supplement 23 · standard — Letter ↗AP
2024-09-17Efficacy · Supplement 21 · standard — Label ↗AP
2024-04-05Efficacy · Supplement 20 · standard — Label ↗AP
2019-10-03Efficacy · Supplement 5 · standard — Label ↗AP
2017-11-14Type 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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