BYLVAY

Albireo Pharma, Inc.🇺🇸 United States

FDA Page

Effective Date: Sep 2, 2026
Approval ID: 151f1d3e-2bf4-47ce-b1be-a892de3258fa
Products: 4 registered
Version: 10

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BYLVAY safely and effectively. See full prescribing information for BYLVAY. BYLVAY (odevixibat) capsules, for oral use BYLVAY (odevixibat) oral pellets Initial U.S. Approval: 2021

Quick Stats

Total Products4

Labelers2

Label Sections32

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.