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Summary

FDA approved VYEPTI (EPTINEZUMAB-JJMR) by Lundbeck Seattle BioPharmaceuticals, Inc.. BLA (Biologic) approval (Labeling) on 2026-06-05. INJECTABLE, INJECTION.

Details

Source

Drug Approval

External ID

BLA761119-15

Action Date

2026-06-05

Status

Approved

Category

drug

Product Code

BLA (Biologic)

Product Description

VYEPTI (generic: EPTINEZUMAB-JJMR), INJECTABLE, INJECTION. Application: BLA761119

Context & Analysis

Frequently Asked Questions

How often does Lundbeck Seattle BioPharmaceuticals, Inc. have FDA actions?

This is the only FDA action we have on record for Lundbeck Seattle BioPharmaceuticals, Inc. in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "BLA761119-15" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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