NDAINTRAVENOUSFOR SUSPENSIONPriority Review
Approved
Jul 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Priority Review
RYANODEX (dantrolene sodium) by Eagle Pharmaceuticals 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. Approved for heat stroke. First approved in 2014.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RYANODEX (dantrolene sodium) is an IV skeletal muscle relaxant that dissociates excitation-contraction coupling by interfering with calcium release from the sarcoplasmic reticulum. It is indicated for malignant hyperthermia crisis, heat stroke, and drug toxicity. The drug acts directly on muscle tissue beyond the neuromuscular junction with a mean half-life of 8.7 hours.
Peak
RYANODEX is in peak commercial stage with moderate competitive pressure (30%), positioning it as a stable revenue contributor for Eagle Pharmaceuticals with established field and medical affairs infrastructure.
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.