Overview
Terbutaline was first synthesized in 1966 and described in the literature in the late 1960s and early 1970s. It is a selective beta-2 adrenergic agonist used as a bronchodilator in asthmatic patients. Terbutaline was granted FDA approval on 25 March 1974.
Background
Terbutaline was first synthesized in 1966 and described in the literature in the late 1960s and early 1970s. It is a selective beta-2 adrenergic agonist used as a bronchodilator in asthmatic patients. Terbutaline was granted FDA approval on 25 March 1974.
Indication
Terbutaline is indicated for prevention and reversal of bronchospasm in patients at least 12 years old, with asthma and reversible bronchospasm associated with bronchitis and emphysema.
Associated Conditions
- Asthma
- Bronchospasm
- Chronic Cough (CC)
- Chronic Obstructive Pulmonary Disease (COPD)
- Cough
- Premature Labour
- Productive cough
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/04 | Phase 3 | Completed | Muhammad Aamir Latif | ||
2022/08/09 | Phase 2 | UNKNOWN | |||
2022/04/13 | Not Applicable | Completed | |||
2022/01/18 | Not Applicable | Recruiting | |||
2021/07/22 | Phase 2 | Suspended | Kanecia Obie Zimmerman | ||
2021/01/12 | Phase 3 | Terminated | |||
2020/07/22 | Phase 2 | UNKNOWN | |||
2020/07/13 | N/A | Completed | |||
2018/06/21 | Not Applicable | UNKNOWN | Morten Hostrup, PhD | ||
2017/04/10 | Phase 4 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Marlex Pharmaceuticals Inc | 10135-580 | ORAL | 5 mg in 1 1 | 1/6/2020 | |
| Lannett Company, Inc. | 0527-1318 | ORAL | 2.5 mg in 1 1 | 7/27/2022 | |
| Rebel Distributors Corp | 21695-121 | ORAL | 5 mg in 1 1 | 3/21/2008 | |
| Medical Purchasing Solutions. LLC | 71872-7080 | SUBCUTANEOUS | 1 mg in 1 mL | 5/23/2023 | |
| Lannett Company, Inc. | 0527-1311 | ORAL | 5 mg in 1 1 | 7/27/2022 | |
| UBI Pharma Inc. | 72843-101 | SUBCUTANEOUS | 1 mg in 1 mL | 2/15/2019 | |
| Amneal Pharmaceuticals of New York LLC | 0115-2622 | ORAL | 5 mg in 1 1 | 1/25/2020 | |
| Henry Schein, Inc. | 0404-9962 | SUBCUTANEOUS | 1 mg in 1 mL | 1/12/2022 | |
| ANI Pharmaceuticals, Inc. | 62559-722 | ORAL | 5 mg in 1 1 | 10/16/2018 | |
| Chartwell RX, LLC. | 62135-525 | ORAL | 5 mg in 1 1 | 3/2/2023 |
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 |
|---|---|---|---|---|---|
| BUTYLIN SYRUP 1.5 mg/5 ml | SIN08075P | SYRUP | 1.5 mg/5 ml | 3/18/1995 | |
| ASMALIN TABLET 2.5 mg | SIN06420P | TABLET | 2.5 mg | 7/8/1991 | |
| ASMALIN SYRUP 1.5 mg/5 ml | SIN07055P | SYRUP | 1.5 mg/5 ml | 6/12/1992 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Terbutaline Sulfate and Sodium Chloride Injection | 国药准字H20050485 | 化学药品 | 注射剂 | 7/16/2020 | |
| Terbutaline Sulfate and Sodium Chloride Injection | 国药准字H20050347 | 化学药品 | 注射剂 | 6/17/2022 | |
| Terbutaline Sulfate Capsules | 国药准字H19991398 | 化学药品 | 胶囊剂 | 2/25/2020 | |
| Terbutaline Sulphate Powder for Inhalation | 国药准字H20030401 | 化学药品 | 粉雾剂 | 7/10/2020 | |
| Terbutaline Sulfate Tablets | 国药准字H19983065 | 化学药品 | 片剂 | 8/13/2021 | |
| Terbutaline Sulfate Tablets | 国药准字H20023170 | 化学药品 | 片剂 | 11/9/2020 | |
| Terbutaline Sulfate Tablets | 国药准字H19993341 | 化学药品 | 片剂 | 11/27/2020 | |
| Terbutaline Sulfate Tablets | 国药准字H32022694 | 化学药品 | 片剂 | 4/17/2020 | |
| Terbutaline Sulfate Tablets | 国药准字H19983193 | 化学药品 | 片剂 | 7/15/2022 | |
| Terbutaline Sulfate Tablets | 国药准字H46020459 | 化学药品 | 片剂 | 7/26/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BUCANIN SYRUP 1.5MG/5ML | N/A | synco (h.k.) limited | N/A | N/A | 9/1/1995 |
| BUCANIN SYRUP 3MG/5ML | N/A | jean-marie pharmacal co ltd | N/A | N/A | 9/1/1995 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Bricanyl 0.5mg/1mL injection ampoule | 12068 | Medicine | A | 8/13/1991 | |
| BRICANYL TURBUHALER terbutaline sulfate 400 microgram powder for inhalation dry powder inhaler | 315075 | Medicine | A | 4/9/2020 |