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
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2003/07/09 | Phase 3 | Completed |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. | 47335-753 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 4/30/2020 | |
| NuCare Pharmaceuticals,Inc. | 68071-2340 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 2/2/2021 | |
| Akorn | 17478-172 | RESPIRATORY (INHALATION) | 0.31 mg in 3 mL | 6/30/2017 | |
| Burel Pharmaceuticals, LLC | 35573-444 | RESPIRATORY (INHALATION) | 0.63 mg in 3 mL | 7/1/2021 | |
| Bryant Ranch Prepack | 72162-2082 | RESPIRATORY (INHALATION) | 0.63 mg in 3 mL | 9/14/2023 | |
| Ritedose Pharmaceuticals, LLC | 76204-002 | RESPIRATORY (INHALATION) | 0.63 mg in 3 mL | 12/21/2012 | |
| Aurobindo Pharma Limited | 65862-945 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 10/31/2023 | |
| Mylan Pharmaceuticals Inc. | 0378-9692 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 11/28/2017 | |
| Teva Pharmaceuticals USA, Inc. | 0093-4147 | RESPIRATORY (INHALATION) | 1.25 mg in 0.5 mL | 1/31/2019 | |
| Dr. Reddys Laboratories, Inc. | 43598-409 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 9/16/2014 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20243992 | 化学药品 | 吸入制剂 | 6/11/2024 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20233123 | 化学药品 | 吸入制剂 | 6/5/2023 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字HJ20220009 | 化学药品 | 吸入制剂（吸入溶液） | 2/18/2022 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20237016 | 化学药品 | 吸入制剂 | 2/9/2023 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20233064 | 化学药品 | 吸入制剂 | 1/19/2023 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20243415 | 化学药品 | 吸入制剂 | 3/29/2024 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20249027 | 化学药品 | 吸入制剂 | 10/9/2024 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20233124 | 化学药品 | 吸入制剂 | 6/5/2023 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20223070 | 化学药品 | 吸入制剂 | 1/30/2022 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20243593 | 化学药品 | 吸入制剂 | 4/24/2024 |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||