NDAORALCAPSULEPriority Review
Approved
Jan 1974
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
DANTRIUM (dantrolene sodium) by Pfizer is clinical pharmacology in isolated nerve-muscle preparation, dantrolene sodium has been shown to produce relaxation by affecting the contractile response of the skeletal muscle at a site beyond the myoneural junction, directly on the muscle itself. First approved in 1974.
Drug data last refreshed 10h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DANTRIUM (dantrolene sodium) is a skeletal muscle relaxant that works by dissociating excitation-contraction coupling in muscle, primarily interfering with calcium release from the sarcoplasmic reticulum. It is indicated for chronic spasticity management and acute malignant hyperthermia treatment and prevention. The drug acts directly on muscle tissue beyond the neuromuscular junction, with effects more pronounced in fast muscle fibers.
LOE Approaching
Product is approaching loss of exclusivity with modest competitive pressure (30), suggesting transition from growth to maintenance phase with potential team restructuring.
Mechanism of Action
CLINICAL PHARMACOLOGY In isolated nerve-muscle preparation, dantrolene sodium has been shown to produce relaxation by affecting the contractile response of the skeletal muscle at a site beyond the myoneural junction, directly on the muscle itself. In skeletal muscle, dantrolene sodium dissociates…
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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.