NDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1979
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
6/8 — Strong
Priority Review
DANTRIUM (dantrolene sodium) by Pfizer is clinical pharmacology: in isolated nerve-muscle preparation, dantrium has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. Approved for malignant hyperthermia. First approved in 1979.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DANTRIUM (dantrolene sodium) is an injectable skeletal muscle relaxant that dissociates excitation-contraction coupling by interfering with calcium release from the sarcoplasmic reticulum. It is indicated for malignant hyperthermia crisis management and prophylaxis, and has been used off-label for heat stroke. The drug works directly on muscle tissue beyond the neuromuscular junction to reduce myoplasmic calcium and reverse hypermetabolic cascade.
$0.010BPart D
LOE ApproachingProduct approaching loss of exclusivity with minimal Part D spending signals declining team investment and consolidation toward generic transition.
Mechanism of Action
CLINICAL PHARMACOLOGY: In isolated nerve-muscle preparation, Dantrium has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. In skeletal muscle, Dantrium dissociates the excitation-contraction coupling, probably by…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.