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FDA BLA · BLA761037

KEVZARA

sarilumab

Sponsor: SANOFI SYNTHELABO

APPLICATION
BLA761037
TYPE
BLA
ORIGINAL APPROVAL
2017-05-22
LATEST ACTION
2024-06-10
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

KEVZARAPrescription
SARILUMAB 150MG/1.14ML · INJECTABLE · INJECTION
KEVZARAPrescription
SARILUMAB 200MG/1.14ML · INJECTABLE · INJECTION

Approval history

2024-06-10Efficacy · Supplement 15 · standard — Letter ↗AP
2023-02-28Efficacy · Supplement 13 · priority — Letter ↗AP
2018-04-13Efficacy · Supplement 1 · standard — Label ↗AP
2017-05-22Type 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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