Application Nr Approved Date Route Status External Links
NDA210557 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Vyleesi Is Indicated For The Treatment Of Premenopausal Women With Acquired, Generalized Hypoactive Sexual Desire Disorder (Hsdd), As Characterized By Low Sexual Desire That Causes Marked Distress Or Interpersonal Difficulty And Is Not Due To: A Co-Existing Medical Or Psychiatric Condition, Problems With The Relationship, Or The Effects Of A Medication Or Drug Substance. Acquired Hsdd Refers To Hsdd That Develops In A Patient Who Previously Had No Problems With Sexual Desire. Generalized Hsdd Refers To Hsdd That Occurs Regardless Of The Type Of Stimulation, Situation Or Partner. Limitations Of Use Vyleesi Is Not Indicated For The Treatment Of Hsdd In Postmenopausal Women Or In Men. Vyleesi Is Not Indicated To Enhance Sexual Performance. Vyleesi Is A Melanocortin Receptor Agonist Indicated For The Treatment Of Premenopausal Women With Acquired, Generalized Hypoactive Sexual Desire Disorder (Hsdd) As Characterized By Low Sexual Desire That Causes Marked Distress Or Interpersonal Difficulty And Is Not Due To: A Co-Existing Medical Or Psychiatric Condition, Problems With The Relationship, Or The Effects Of A Medication Or Drug Substance ( 1 ) Limitations Of Use ( 1 ): Not Indicated For Treatment Of Hsdd In Postmenopausal Women Or In Men. Not Indicated To Enhance Sexual Performance.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Bremelanotide Acetate

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