Flibanserin tablet

Form: Tablet

Strength: 100 mg

Reference Brands: Addyi(US)

Category: Sexual Wellness

Flibanserin tablets, marketed as Addyi, are approved in the US by the FDA for the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD). Regulatory requirements include a comprehensive dossier with clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA conducts detailed review processes, while the EU’s EMA assesses compliance with regional safety and quality standards—though approval in Europe remains pending or varies by country. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring thorough compliance supports timely approval, safe use, and broader global availability, improving quality of life for women worldwide.