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FDA BLA · BLA761083

HEMLIBRA

emicizumab

Sponsor: GENENTECH INC

APPLICATION
BLA761083
TYPE
BLA
ORIGINAL APPROVAL
2017-11-16
LATEST ACTION
2025-07-08
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HEMLIBRAPrescription
EMICIZUMAB 60MG/0.4ML · INJECTABLE · INJECTION
HEMLIBRAPrescription
EMICIZUMAB 105MG/0.7ML · INJECTABLE · INJECTION
HEMLIBRAPrescription
EMICIZUMAB 30MG/ML · INJECTABLE · INJECTION
HEMLIBRAPrescription
EMICIZUMAB 150MG · INJECTABLE · INJECTION

Approval history

2025-07-08Labeling · Supplement 20 · standard — Letter ↗AP
2024-01-31Labeling · Supplement 18 · standard — Letter ↗AP
2022-06-06Labeling · Supplement 15 · standard — Letter ↗AP
2021-12-16Labeling · Supplement 13 · standard — Label ↗AP
2021-09-02Labeling · Supplement 11 · standard — Letter ↗AP
2018-10-04Efficacy · Supplement 4 · priority — Label ↗AP
2018-10-04Efficacy · Supplement 2 · priority — Label ↗AP
2017-11-16Type 1 - New Molecular Entity · Original · priority — 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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