ARTICLE | Clinical News
AbbVie's elagolix NDA PFUDA pushed to third quarter
April 13, 2018 5:55 PM UTC
AbbVie Inc. (NYSE:ABBV) said FDA extended by three months its review of an NDA for elagolix (ABT-620) to manage endometriosis with associated pain. The candidate's PDUFA date is now in 3Q18. The exact date is not disclosed.
According to AbbVie, FDA extended the review to evaluate additional liver function data provided by the company...