Vardenafil tablet

Form: Tablet

Strength: 5 mg, 10 mg, 20 mg

Reference Brands: Levitra, Staxyn(US & EU)

Category: Sexual Wellness

Vardenafil tablets, marketed as Levitra and Staxyn, are approved in the US by the FDA and in the EU via EMA for erectile dysfunction. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical trial and quality data, while the EMA ensures compliance with regional safety standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance is essential for timely approval, safe use, and global availability of vardenafil tablets, supporting effective management of ED worldwide across diverse patient populations.