← FDA DRUG APPROVALS

FDA BLA · BLA761328

BEYFORTUS

nirsevimab

Sponsor: ASTRAZENECA AB

APPLICATION
BLA761328
TYPE
BLA
ORIGINAL APPROVAL
2023-07-17
LATEST ACTION
2026-04-07
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BEYFORTUSPrescription
NIRSEVIMAB-ALIP 50MG · INJECTABLE · INJECTION
BEYFORTUSPrescription
NIRSEVIMAB-ALIP 100MG · INJECTABLE · INJECTION

Approval history

2026-04-07Labeling · Supplement 19 · standard — Letter ↗AP
2025-10-20Efficacy · Supplement 12 · standard — Label ↗AP
2024-08-22Efficacy · Supplement 5 · standard — Letter ↗AP
2024-02-23Labeling · Supplement 7 · 901 required — Label ↗AP
2023-07-17Type 1 - New Molecular Entity · Original · standard — Label ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →