TERBUTALINE SULFATE
TERBUTALINE SULFATE is indicated for the treatment of Asthma; Bronchitis; Emphysema.
Details
- Status
- Discontinued
- First Approved
- 2001-06-26
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET
Companies
TERBUTALINE SULFATE Approval History
What TERBUTALINE SULFATE Treats
3 indicationsTERBUTALINE SULFATE is approved for 3 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Bronchitis
- Emphysema
TERBUTALINE SULFATE Boxed Warning
TOCOLYSIS Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema...
WARNING: TOCOLYSIS Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration. [see Contraindications, Tocolysis . ]
TERBUTALINE SULFATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TERBUTALINE SULFATE
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TERBUTALINE SULFATE FDA Label Details
Indications & Usage
TERBUTALINE SULFATE is indicated for the treatment of Asthma; Bronchitis; Emphysema.
WARNING: TOCOLYSIS Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been report...
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BRETHINE
Full clinical data, patents, trials, and competitive landscape for terbutaline sulfate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.