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Orilissa FDA Approval History

FDA Approved: Yes (First approved July 23, 2018)
Brand name: Orilissa
Generic name: elagolix
Dosage form: Tablets
Company: AbbVie Inc.
Treatment for: Endometriosis

Orilissa (elagolix) is an orally administered gonadotropin-releasing hormone (GnRH) antagonist for the management of moderate to severe pain associated with endometriosis.

Development Timeline for Orilissa

DateArticle
Jul 24, 2018Approval FDA Approves Orilissa (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis
Apr 10, 2018AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain
Mar 13, 2018AbbVie Announces Positive Topline Results from Second Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids
Feb 21, 2018AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids
Oct 27, 2017AbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain
Sep  6, 2017AbbVie Submits New Drug Application to FDA for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain

Further information

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