NDAINTRAVENOUSSOLUTION
Approved
Jul 2009
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
SOTALOL HYDROCHLORIDE (sotalol hydrochloride) by AltaThera Pharmaceuticals is beta-adrenoreceptor blocking (vaughan williams class ii) and cardiac action potential duration prolongation (vaughan williams class iii) antiarrhythmic properties. Approved for documented, life-threatening ventricular arrhythmias, such. First approved in 2009.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Sotalol hydrochloride is an intravenous antiarrhythmic agent combining non-selective beta-adrenergic blockade (Class II) with cardiac action potential prolongation (Class III) properties. It is indicated for documented, life-threatening ventricular arrhythmias and works through dual mechanisms: the l-isomer provides beta-blocking activity while both isomers contribute Class III electrophysiologic effects. The drug is administered as an IV solution with therapeutic effects observable at doses as low as 75 mg.
Peak12.9 years to LOE
Product is at peak commercial stage with stable market position; teams maintaining mature brand infrastructure with focus on retention and clinical education.
Mechanism of Action
beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Intravenous sotalol is a racemic mixture of d- and l-sotalol. Both isomers have similar Class III antiarrhythmic effects, while the…
Indications (3)
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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.