LYBALVI

Alkermes, Inc.🇺🇸 United States

FDA Page

Effective Date: Jan 31, 2024
Approval ID: 32ffddd1-4e2b-45d9-9b36-bb730167ec80
Products: 0 registered
Version: 8

Regulatory Information

Labeling Type

34391-3

Status

Approved

Full Title

{"sup": ["®", "®", "®"], "br": [null, null, null], "#text": "These highlights do not include all the information needed to use LYBALVI safely and effectively. See full prescribing information for LYBALVI.\n LYBALVI (olanzapine and samidorphan) tablets, for oral useInitial U.S. Approval: 2021"}

Quick Stats

Total Products0

Labelers1

Label Sections30

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.