NDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1979
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, dantrium has been shown to produce relaxation by affecting the contractile response of the muscle at a site beyond the myoneural junction. First approved in 1979.
Drug data last refreshed 19h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Dantrium (dantrolene sodium) is a skeletal muscle relaxant that works by inhibiting calcium release from the sarcoplasmic reticulum, dissociating excitation-contraction coupling. It is approved for acute management and prophylaxis of malignant hyperthermia, a rare but life-threatening pharmacogenetic crisis triggered by certain anesthetics. The drug has also been used off-label for other conditions involving pathologic muscle contractions.
$0.01BPart D
LOE ApproachingMature niche product with minimal commercial activity and declining patient claims, indicating a small, specialized team focused on maintenance rather than growth.
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.