AbbVie seeks FDA nod for Elagolix
India, Aug. 19 -- AbbVie, a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. have announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elagolix, an investigational, oral gonadotropin-releasing hormone (GnRH) antagonist, for the management of heavy menstrual bleeding (HMB) associated with uterine fibroids in women.
Uterine fibroids are non-cancerous, hormonally-responsive muscle tissue tumors of the uterus.They can affect up to 70% of Caucasian women and up to 80% of African American women by age 50.Fibroids can be asymptomatic but, in some women, fibroids can cause symptoms, such as heavy menstrual bleeding (HMB), vaginal bleeding at t...
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