FDA.reportPublic FDA data

OMALIZUMAB Pharmacologic Class Indexing

Class set ID
96ca84b1-cfac-49fa-8826-25b16a3be4df
Version
2
Effective date
20180813
Type
Indexing - Pharmacologic Class

Mapped DailyMed Labels#

Label, Manufacturer, Effective table
LabelManufacturerEffectiveSPL version
These highlights do not include all the information needed to use OMALIZUMAB-IGEC safely and effectively. See full prescribing information for OMALIZUMAB-IGEC. OMALIZUMAB-IGEC injection, for subcutaneous use Initial U.S. Approval: 2025 Omalizumab-igec is biosimilar 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 theCELLTRION, Inc.202512054
These highlights do not include all the information needed to use XOLAIR safely and effectively. See full prescribing information for XOLAIR. XOLAIR ® (omalizumab) injection, for subcutaneous use XOLAIR ® (omalizumab) for injection, for subcutaneous use Initial U.S. Approval: 2003Genentech, Inc. | Roche Diagnostics GmbH2025120231