Bremelanotide Sq Injection

Form: Injection(SQ)

Strength: 1.75 mg

Reference Brands: Vyleesi (US)

Category: Sexual Wellness

Bremelanotide SQ injection, marketed as Vyleesi, is approved in the US by the FDA for premenopausal women with hypoactive sexual desire disorder (HSDD). In the EU, it remains under review or pending approval. Regulatory approval requires a detailed dossier including clinical efficacy, safety, manufacturing quality, and pharmacovigilance plans. In the US, the FDA rigorously reviews clinical trial data and manufacturing standards, while the EMA ensures compliance with regional safety and quality requirements. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring adherence to regional regulations supports timely approval and safe, effective availability of Bremelanotide worldwide.