DANTRIUM
Details
- Status
- Prescription
- First Approved
- 1974-01-15
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, CAPSULE
DANTRIUM Approval History
What DANTRIUM Treats
1 indicationsDANTRIUM is approved for 1 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Malignant Hyperthermia
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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.
DANTRIUM FDA Label Details
ProIndications & Usage
FDA Label (PDF): Dantrium Intravenous is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. Dantrium Intravenous should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in ma...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.