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

Xolair PFS
Manufacturer:Genentech, Inc.
Route:SUBCUTANEOUS
Strength:150 mg in 1 mL
Approved: 2024/02/22
NDC:50242-215
Xolair PFS
Manufacturer:Genentech, Inc.
Route:SUBCUTANEOUS
Strength:75 mg in 0.5 mL
Approved: 2024/02/22
NDC:50242-214
XOLAIR
Manufacturer:Genentech, Inc.
Route:SUBCUTANEOUS
Strength:150 mg in 1.2 mL
Approved: 2024/02/22
NDC:50242-040
Xolair
Manufacturer:Genentech, Inc.
Route:SUBCUTANEOUS
Strength:300 mg in 2 mL
Approved: 2024/02/22
NDC:50242-227

Singapore Approved Products

XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 150MG/1.0ML
Manufacturer:Vetter Pharma-Fertigung GmbH & Co. KG
Form:INJECTION, SOLUTION
Strength:150 mg/1.0 mL
Online:Yes
Approved: 2021/03/04
Approval:SIN16116P
Xolair 150mg Powder and Solvent for Solution for Injection
Manufacturer:Takeda Austria GmbH, Novartis Pharma Stein AG, DELPHARM DIJON - QUETIGNY
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:150mg
Online:Yes
Approved: 2006/07/07
Approval:SIN13212P
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 75MG/0.5ML
Manufacturer:Vetter Pharma-Fertigung GmbH & Co. KG
Form:INJECTION, SOLUTION
Strength:75mg/0.5ml
Online:Yes
Approved: 2021/03/04
Approval:SIN16115P
Xolair 75mg Powder and Solvent for Solution for Injection
Manufacturer:Novartis Pharma Stein AG, Takeda Austria GmbH, DELPHARM DIJON - QUETIGNY
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:75mg
Online:Yes
Approved: 2006/07/07
Approval:SIN13213P
XOLAIR SOLUTION FOR INJECTION IN PRE-FILLED PEN 75MG/0.5ML
Manufacturer:Novartis Pharma Stein AG
Form:INJECTION, SOLUTION
Strength:75.00 mg/0.5 mL
Online:Yes
Approved: 2024/06/21
Approval:SIN17030P

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