MedPath

Levosalbutamol

Generic Name
Levosalbutamol
Brand Names
Xopenex
Drug Type
Small Molecule
Chemical Formula
C13H21NO3
CAS Number
34391-04-3
Unique Ingredient Identifier
EDN2NBH5SS

Overview

Levosalbutamol, or levalbuterol, is a short-acting β2 adrenergic receptor agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Salbutamol has been marketed as a racemic mixture, although beta2-agonist activity resides almost exclusively in the (R)-enantiomer. The enantioselective disposition of salbutamol and the possibility that (S)-salbutamol has adverse effects have led to the development of an enantiomerically pure (R)-salbutamol formulation known as levosalbutamol (levalbuterol).

Background

Levosalbutamol, or levalbuterol, is a short-acting β2 adrenergic receptor agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Salbutamol has been marketed as a racemic mixture, although beta2-agonist activity resides almost exclusively in the (R)-enantiomer. The enantioselective disposition of salbutamol and the possibility that (S)-salbutamol has adverse effects have led to the development of an enantiomerically pure (R)-salbutamol formulation known as levosalbutamol (levalbuterol).

Indication

Indicated for the management of COPD (chronic obstructive pulmonary disease, also known as chronic obstructive lung disease) and asthma.

Associated Conditions

  • Bronchospasm

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Dr. Reddys Laboratories, Inc.
43598-412
RESPIRATORY (INHALATION)
0.31 mg in 3 mL
9/16/2014
Akorn
17478-173
RESPIRATORY (INHALATION)
0.63 mg in 3 mL
6/30/2017
Amneal Pharmaceuticals of New York LLC
0115-9931
RESPIRATORY (INHALATION)
0.63 mg in 3 mL
6/29/2019
Ritedose Pharmaceuticals, LLC
76204-700
RESPIRATORY (INHALATION)
0.31 mg in 3 mL
12/20/2023
A-S Medication Solutions
50090-6377
RESPIRATORY (INHALATION)
0.63 mg in 3 mL
8/3/2022
NuCare Pharmaceuticals,Inc.
68071-5027
RESPIRATORY (INHALATION)
1.25 mg in 3 mL
2/19/2021
Mylan Pharmaceuticals Inc.
0378-6993
RESPIRATORY (INHALATION)
1.25 mg in 0.5 mL
8/29/2017
Sun Pharmaceutical Industries, Inc.
47335-743
RESPIRATORY (INHALATION)
0.31 mg in 3 mL
4/30/2020
Akorn
17478-174
RESPIRATORY (INHALATION)
1.25 mg in 3 mL
6/30/2017
Burel Pharmaceuticals, LLC
35573-443
RESPIRATORY (INHALATION)
0.31 mg in 3 mL
7/1/2021

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Levosalbutamol Hydrochloride Nebuliser Solution
国药准字H20234008
化学药品
吸入制剂
8/1/2023
Levosalbutamol Hydrochloride Nebuliser Solution
国药准字H20223069
化学药品
吸入制剂
1/30/2022
Levosalbutamol Hydrochloride Nebuliser Solution
国药准字H20253376
化学药品
吸入制剂
2/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution
国药准字H20193279
化学药品
吸入制剂(吸入溶液)
9/26/2019
Levosalbutamol Hydrochloride Nebuliser Solution
国药准字H20253611
化学药品
吸入制剂
3/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution
国药准字H20253617
化学药品
吸入制剂
3/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution
国药准字H20253610
化学药品
吸入制剂
3/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution
国药准字H20253618
化学药品
吸入制剂
3/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution
国药准字H20253616
化学药品
吸入制剂
3/11/2025
Levosalbutamol Hydrochloride Nebuliser Solution
国药准字H20243408
化学药品
吸入制剂
3/29/2024

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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