NDAORALSOLUTION
Approved
Oct 2014
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
SOTYLIZE (sotalol hydrochloride) by R-Pharm US 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 2014.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOTYLIZE is an oral solution formulation of sotalol hydrochloride, a dual-action antiarrhythmic combining non-cardioselective beta-blockade (Class II) with cardiac action potential prolongation (Class III). It is indicated for documented, life-threatening ventricular arrhythmias. The drug works by reducing heart rate through beta-adrenergic receptor blocking and prolonging the cardiac action potential duration at doses ≥160 mg/day.
$0.018BPart D
Peak9.2 years to LOESOTYLIZE is in peak commercial phase with modest Medicare claims volume; team size is likely small given niche indication and low spending, indicating career advancement may require transition planning.
Mechanism of Action
beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. The two isomers of sotalol have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of 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.