PDUFA date for FDA review of ulipristal acetate for treatment of uterine fibroids is extended to August 2018. - Allergan

Allergan plc, announced that it was notified by the FDA) that the review of the New Drug Application (NDA) for ulipristal acetate as a pre-operative treatment of moderate to severe symptoms of Uterine Fibroids. will be extended. The PDUFA target action date has been extended to August 2018 to provide time for a full review of the file.

Comment:The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya from Gedeon Richter + Allergan, following reports of serious liver injury, including liver failure leading to transplantation. As a temporary measure while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking Esmya for uterine fibroids.