Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Status
Approved
Full Title
These highlights do not include all the information needed to use BYOOVIZ safely and effectively. See full prescribing information for BYOOVIZ. BYOOVIZ ® (ranibizumab-nuna) injection, for intravitreal use Initial U.S. Approval: 2021 BYOOVIZ (ranibizumab-nuna) is biosimilar to LUCENTIS (ranibizumab injection) - Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of BYOOVIZ has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.
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.
