HEMABATE (carboprost tromethamine)
HEMABATE is indicated for the treatment of Postpartum Hemorrhage; Uterine Atony.
Details
- Status
- Prescription
- First Approved
- 1979-01-09
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HEMABATE Approval History
What HEMABATE Treats
2 indicationsHEMABATE is approved for 2 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Postpartum Hemorrhage
- Uterine Atony
HEMABATE Boxed Warning
WARNINGS HEMABATE Sterile Solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. HEMABATE should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities....
WARNINGS HEMABATE Sterile Solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. HEMABATE should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.
HEMABATE 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.
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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.
HEMABATE FDA Label Details
Indications & Usage
FDA Label (PDF)HEMABATE is indicated for the treatment of Postpartum Hemorrhage; Uterine Atony.
WARNINGS HEMABATE Sterile Solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. HEMABATE should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facili...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.