Sotalol Tablet

Form: Tablet

Strength: 80 mg, 120 mg, 160 mg, 240 mg

Reference Brands: Betapace:(US & EU)

Category: Heart Disorder

Sotalol tablets, marketed as Betapace, are approved in the US by the FDA and in the EU via EMA for treating atrial and ventricular arrhythmias. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical trial results and manufacturing quality, while, in the EU, the EMA ensures compliance with safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance facilitates timely approval, safe use, and global availability of sotalol tablets, supporting effective arrhythmia management worldwide.