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 .

Indication

This drug is an anti-IgE antibody indicated for:

Associated Conditions

  • Chronic Idiopathic Urticaria
  • Moderate Asthma
  • Severe Asthma

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Genentech, Inc.
50242-215
SUBCUTANEOUS
150 mg in 1 mL
2/22/2024
Genentech, Inc.
50242-227
SUBCUTANEOUS
300 mg in 2 mL
2/22/2024
Genentech, Inc.
50242-214
SUBCUTANEOUS
75 mg in 0.5 mL
2/22/2024
Genentech, Inc.
50242-040
SUBCUTANEOUS
150 mg in 1.2 mL
2/22/2024

HSA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Omalizumab Injection
国药准字SJ20220016
生物制品
注射剂
8/30/2022
Omalizumab alfa for Injection
国药准字S20230030
生物制品
注射剂
5/19/2023
Omalizumab alfa for Injection
国药准字S20230031
生物制品
注射剂
5/19/2023
Omalizumab for Injection
国药准字SJ20170042
生物制品
注射剂
1/27/2022
Omalizumab for Injection
国药准字S20240043
生物制品
注射剂
9/26/2024

TGA Drug Approvals

Help Us Improve

Your feedback helps us provide better drug information and insights.

© Copyright 2025. All Rights Reserved by MedPath