AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain

PRNewswire

Apr 10, 2018

- FDA requires extended time for review of additional information in New Drug Application (NDA)

- Elagolix clinical trial program largest prospective randomized endometriosis trial conducted to date

- Based on AbbVie's review of the data, the company remains confident in NDA and continues to work with FDA to bring elagolix to patients

- Regulatory submissions for elagolix in uterine fibroids remain on track

PR Newswire

NORTH CHICAGO, Ill., April 10, 2018

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