NDAINTRAVENOUSFOR SUSPENSIONPriority Review
Approved
Jul 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
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. First approved in 2014.
Drug data last refreshed 7h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RYANODEX (dantrolene sodium) is an intravenous skeletal muscle relaxant that treats malignant hyperthermia by dissociating excitation-contraction coupling and interfering with calcium release from the sarcoplasmic reticulum. It is the only FDA-approved IV formulation specifically indicated for acute malignant hyperthermia crisis management and prophylaxis in susceptible patients. The drug acts directly on skeletal muscle rather than the neuromuscular junction, with effects more pronounced in fast-twitch fibers.
Peak
At peak lifecycle stage with moderate competitive pressure (30), suggesting stable to maturing commercial infrastructure and established field team presence.
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.