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FDA BLA · BLA125349

RAXIBACUMAB

Sponsor: HUMAN GENOME SCIENCES INC.

APPLICATION
BLA125349
TYPE
BLA
ORIGINAL APPROVAL
2012-12-14
LATEST ACTION
2021-06-02
ROUTE
INTRAVENOUS, IV (INFUSION)
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

RAXIBACUMABPrescription
RAXIBACUMAB 1700MG/34ML (50MG/ML) · INJECTABLE · IV (INFUSION)

Approval history

2021-06-02Labeling · Supplement 26 · standard — Letter ↗AP
2018-01-11Efficacy · Supplement 22 · priority — Label ↗AP
2012-12-14Type 1 - New Molecular Entity · Original · priority — Summary Review ↗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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