Product/Composition:- | Bremelanotide Sq Injection |
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Strength:- | 1.75 mg |
Form:- | Injection(SQ) |
Reference Brands:- | Vyleesi (US) |
MOQ | As per the manufacturer batch size |
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Bremelanotide is a melanocortin receptor agonist that stimulates pathways involved in sexual desire. It increases blood flow and arousal, helping women with hypoactive sexual desire disorder (HSDD). Benefits include rapid onset, improved libido, enhanced intimacy, and increased confidence, supporting better sexual health and partner satisfaction.
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.