Myfembree

Sumitomo Pharma America, Inc🇺🇸 United States

FDA Page

Effective Date: Jan 18, 2024
Approval ID: fc3feb73-cc84-43a8-aa32-b262460495e8
Products: 1 registered
Version: 15

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use MYFEMBREE safely and effectively. See full prescribing information for MYFEMBREE. MYFEMBREE (relugolix, estradiol, and norethindrone acetate) tablets, for oral use Initial U.S. Approval: 2021

Quick Stats

Total Products1

Labelers2

Label Sections28

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.