flibanserin

FDA Drug Profile — ADDYI

Drug Details

Generic Name
flibanserin
Brand Names
ADDYI
Application Number
NDA022526
Sponsor
Bidachem S.p.a.
NDC Codes
2
Dosage Forms
POWDER, TABLET, FILM COATED
Routes
ORAL
Active Ingredients
FLIBANSERIN

Indications and Usage

1 INDICATIONS AND USAGE ADDYI is indicated for the treatment of women less than 65 years of age 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 within the relationship, or • The effects of a medication or other 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 • ADDYI is not indicated in men. • ADDYI is not indicated to enhance sexual performance. ADDYI is indicated for the treatment of women less than 65 years of age 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 ( 1 ): • A co-existing medical or psychiatric condition, • Problems within the relationship, or • The effects of a medication or other drug substance. Limitations of Use: • ADDYI is not indicated in men (1) • ADDYI is not indicated to enhance sexual performance. ( 1 )