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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2009/01/09 | Phase 4 | Terminated | |||
2008/12/17 | Phase 3 | Completed | |||
2008/05/28 | Phase 3 | Completed | |||
2008/05/28 | Phase 2 | Completed | |||
2008/05/28 | Phase 3 | Completed | |||
2008/05/28 | Phase 2 | Completed | |||
2008/05/28 | Phase 2 | Completed | |||
2008/05/28 | Phase 2 | Completed | |||
2008/04/28 | Phase 3 | Completed | |||
2008/04/28 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-5459 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 12/1/2009 | |
| Ritedose Pharmaceuticals, LLC | 76204-003 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 12/21/2012 | |
| Bryant Ranch Prepack | 72162-2083 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 9/14/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-4145 | RESPIRATORY (INHALATION) | 0.31 mg in 3 mL | 1/31/2019 | |
| Physicians Total Care, Inc. | 54868-6021 | RESPIRATORY (INHALATION) | 1.25 mg in 0.5 mL | 12/1/2009 | |
| Mylan Pharmaceuticals Inc. | 0378-9690 | RESPIRATORY (INHALATION) | 0.31 mg in 3 mL | 11/28/2017 | |
| Proficient Rx LP | 63187-953 | RESPIRATORY (INHALATION) | 0.63 mg in 3 mL | 12/1/2018 | |
| Mylan Pharmaceuticals Inc. | 0378-9691 | RESPIRATORY (INHALATION) | 0.63 mg in 3 mL | 11/28/2017 | |
| Rebel Distributors Corp | 21695-153 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 6/3/2010 | |
| Teva Pharmaceuticals USA, Inc. | 0093-4148 | RESPIRATORY (INHALATION) | 1.25 mg in 3 mL | 1/31/2019 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20233264 | 化学药品 | 吸入制剂 | 3/7/2023 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20234384 | 化学药品 | 吸入制剂 | 3/6/2024 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20223805 | 化学药品 | 吸入制剂 | 11/8/2022 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20234010 | 化学药品 | 吸入制剂 | 8/1/2023 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20243993 | 化学药品 | 吸入制剂 | 6/11/2024 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20223168 | 化学药品 | 吸入制剂 | 3/22/2022 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字HJ20220008 | 化学药品 | 吸入制剂（吸入溶液） | 2/18/2022 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20223806 | 化学药品 | 吸入制剂 | 11/8/2022 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20243414 | 化学药品 | 吸入制剂 | 3/29/2024 | |
| Levosalbutamol Hydrochloride Nebuliser Solution | 国药准字H20243592 | 化学药品 | 吸入制剂 | 4/24/2024 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||