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Reduces allergic reactions (Type I), including anaphylaxis. Sold as Omlyclo. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Omalizumab-Igec (sold as Omlyclo), first approved Mar 7, 2025, with 0 new uses approved and 0 published complete response letters.
First approved: Mar 7, 2025
Applications: 1
New uses approved: 0
Complete response letters: 0
First approved in the EU: Oct 25, 2005
First approved in Japan: Jan 21, 2009
Approvals in the EU (EMA)
First approved in the EU 232 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
First approved in Japan 193 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
XolairDrugs with a new additional indication and a new dosage for the treatment of seasonal allergic rhinitis (for use only in severe or the most severe patients… · Novartis Pharma K.K. · Dec 11, 2019
XolairDrugs with a new additional indication and a new dosage for the treatment of chronic idiopathic urticaria (for use only in patients who have not responded… · Novartis Pharma K.K. · Mar 24, 2017
XolairDrugs with a new dosage indicated for the treatment of bronchial asthma (for use only in patients with intractable bronchial asthma whose asthmatic… · Novartis Pharma K.K. · Aug 20, 2013
Xolair, new ingredientA drug containing a new active ingredient indicated for the treatment of bronchial asthma (for use only in patients with intractable bronchial asthma whose… · Novartis Pharma K.K. · Jan 21, 2009 · Review report
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
