NDAORALCAPSULEPriority Review
Approved
Jun 1950
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
PRONESTYL (procainamide hydrochloride) by Bristol Myers Squibb is clinical pharmacology procainamide (pa) increases the effective refractory period of the atria, and to a lesser extent the bundle of his-purkinje system and ventricles of the heart. Approved for documented ventricular arrhythmias, such, that and 1 more indications. First approved in 1950.
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRONESTYL (procainamide hydrochloride) is a Group 1A antiarrhythmic agent approved in 1950 for treatment of documented ventricular arrhythmias. It works by increasing the effective refractory period of cardiac tissue, slowing conduction velocity, and reducing myocardial excitability to suppress ectopic pacemaker activity. The drug is available as an oral capsule formulation.
LOE Approaching
Product is approaching loss of exclusivity with minimal current linked job activity, indicating a mature/declining commercial team structure.
Mechanism of Action
CLINICAL PHARMACOLOGY Procainamide (PA) increases the effective refractory period of the atria, and to a lesser extent the bundle of His-Purkinje system and ventricles of the heart. It reduces impulse conduction velocity in the atria, His-Purkinje fibers, and ventricular muscle, but has variable…
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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.