Kuvan

BioMarin Pharmaceutical Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 26, 2024
Approval ID: af38711e-8873-4790-a92d-4d583e23fb89
Products: 3 registered
Version: 76

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use KUVAN safely and effectively. See full prescribing information for KUVAN. KUVAN (sapropterin dihydrochloride) tablets, for oral useKUVAN (sapropterin dihydrochloride) powder, for oral solutionInitial U.S. Approval: 2007

Quick Stats

Total Products3

Labelers2

Label Sections38

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.