Dapoxetine tablets

Form: Tablet

Strength: 30 mg and 60 mg t

Reference Brands: Priligy(US & EU)

Category: Sexual Wellness

Dapoxetine tablets, marketed as Priligy, are approved in the EU for premature ejaculation but are not approved in the US by the FDA. Regulatory approval in the EU requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The US FDA has not granted approval, citing insufficient data. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance with regional requirements is essential for timely approval, safe use, and global availability, supporting men’s sexual health and confidence worldwide. Proper documentation and adherence to regional standards are crucial for successful market entry and regulatory approval in Europe.