MedPath

Omalizumab

Generic Name
Omalizumab
Brand Names
Xolair, Omlyclo
Drug Type
Biotech
CAS Number
242138-07-4
Unique Ingredient Identifier
2P471X1Z11

Overview

Omalizumab, manufactured by Genentech, was first FDA approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma which is not controlled by inhaled steroids . Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated . In September 2018, a new prefilled syringe formulation of this drug was approved by the FDA .

Background

Omalizumab, manufactured by Genentech, was first FDA approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma which is not controlled by inhaled steroids . Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated . In September 2018, a new prefilled syringe formulation of this drug was approved by the FDA .

Indication

This drug is an anti-IgE antibody indicated for:

Associated Conditions

  • Chronic Idiopathic Urticaria
  • Moderate Asthma
  • Severe Asthma

FDA Approved Products

No FDA products found for this drug

Singapore Approved Products

XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED PEN 300MG/2.0ML
Manufacturer:Novartis Pharma Stein AG
Form:INJECTION, SOLUTION
Strength:300.00 mg / 2.0 mL
Online:Yes
Approved: 2024/06/21
Approval:SIN17032P
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED PEN 150MG/1.0ML
Manufacturer:Novartis Pharma Stein AG
Form:INJECTION, SOLUTION
Strength:150.00 mg/1.0 mL
Online:Yes
Approved: 2024/06/21
Approval:SIN17031P
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 300MG/2.0ML
Manufacturer:Novartis Pharma Stein AG
Form:INJECTION, SOLUTION
Strength:300.00 mg/2.0 mL
Online:Yes
Approved: 2024/06/21
Approval:SIN17029P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath