FDA Requires More Time to Review Abbvie and Neurocrine Endometriosis Drug Elagolix

AbbVie and Neurocrine announced notification by the U.S. Food and Drug Administration (FDA) that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie in connection with its New Drug Application (NDA) for elagolix in endometriosis-associated pain. The Prescription Drug User Fee Act (PDUFA) date has been extended three months to Q3 2018.