Epclusa Access

Gilead Sciences, Inc.🇺🇸 United States

FDA Page

Effective Date: Jul 16, 2026
Approval ID: 996466df-f236-4804-b10f-838aa83231a1
Products: 1 registered
Version: 7

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use EPCLUSA safely and effectively. See full prescribing information for EPCLUSA. EPCLUSA™ (sofosbuvir and velpatasvir) tablets, for oral use Initial U.S. Approval: 2016 GILEAD ACCESS PROGRAM

Quick Stats

Total Products1

Labelers2

Label Sections22

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.