Orladeyo

BioCryst Pharmaceuticals Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 20, 2026
Approval ID: 3527ece1-e7e0-40b1-b0c5-6baeb0deabeb
Products: 2 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 ORLADEYO safely and effectively. See full prescribing information for ORLADEYO. ORLADEYO (berotralstat) capsules, for oral use ORLADEYO (berotralstat) oral pellets Initial U.S. Approval: 2020

Quick Stats

Total Products2

Labelers2

Label Sections19

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.