← FDA DRUG APPROVALS

FDA BLA · BLA761119

VYEPTI

eptinezumab-jjmr

Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.

APPLICATION
BLA761119
TYPE
BLA
ORIGINAL APPROVAL
2020-02-21
LATEST ACTION
2026-06-05
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VYEPTIPrescription
EPTINEZUMAB-JJMR 100MG/ML · INJECTABLE · INJECTION

Approval history

2026-06-05Labeling · Supplement 15 · standard — Letter ↗AP
2025-10-22Efficacy · Supplement 11 · standard — Letter ↗AP
2025-08-18Efficacy · Supplement 10 · standardAP
2025-03-21Labeling · Supplement 12 · standard — Label ↗AP
2025-03-21Labeling · Supplement 9 · standard — Label ↗AP
2022-10-21Labeling · Supplement 6 · standard — Letter ↗AP
2021-09-24Labeling · Supplement 2 · standard — Letter ↗AP
2020-02-21Type 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 →