FDA LABEL RECORD

Vyleesi

BREMELANOTIDE. FDA prescribing information for this product, as published on the retrieval date below.

AS THE LABEL RECORDS IT

Product details

Brand nameVyleesi
Generic nameBREMELANOTIDE
LabellerCosette Pharmaceuticals, Inc.
RouteSUBCUTANEOUS
Label version1
Effective2025-11-13
Retrieved by this site2026-10-03
Full labelhttps://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf

INDICATIONS AND USAGE

Quoted from the FDA label

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.

What this page is

A reproduction of a public FDA label record. Everything quoted above is the labeller's wording as published by the FDA, not this site's. Nothing here is regulatory, legal or medical advice, and a label being reproduced says nothing about whether a product is available in any particular country. Labels are revised often; the retrieval date above says when this copy was taken, and the full current label is at the link.

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