Bylvay

Ipsen Biopharmaceuticals, Inc.🇺🇸 United States

FDA Page

Effective Date: Feb 12, 2024
Approval ID: 0935cd31-3251-4a0a-ac23-25ca4be12be9
Products: 0 registered
Version: 2

Regulatory Information

Labeling Type

34391-3

Status

Approved

Full Title

{"br": [null, null, null, null], "#text": "These highlights do not include all the information needed to use BYLVAY safely and effectively. See full prescribing information for BYLVAY. \n BYLVAY (odevixibat) capsules, for oral use BYLVAY (odevixibat) oral pellets Initial U.S. Approval: 2021"}

Quick Stats

Total Products0

Labelers1

Label Sections21

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.