← FDA DRUG APPROVALS

FDA BLA · BLA761169

INMAZEB

atoltivimab, maftivimab, and odesivimab-ebgn

Sponsor: REGENERON PHARMACEUTICALS

APPLICATION
BLA761169
TYPE
BLA
ORIGINAL APPROVAL
2020-10-14
LATEST ACTION
2024-10-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

INMAZEBPrescription
ATOLTIVIMAB 16.7MG/1ML, ODESIVIMAB, MAFTIVIMAB · SOLUTION · INJECTION

Approval history

2024-10-24Labeling · Supplement 11 · standard — Label ↗AP
2022-05-13Labeling · Supplement 3 · standard — Letter ↗AP
2021-09-29Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2020-10-14Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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