ARTICLE | Clinical News

FDA extends review for Allergan's ulipristal acetate

March 9, 2018 6:35 PM UTC

Allergan plc (NYSE:AGN) said FDA extended its review of an NDA for ulipristal acetate (Ella, ellaOne, PGL4001) to treat abnormal uterine bleeding in women with uterine fibroids. The company had previously expected a decision from FDA in 1H18; the new PDUFA date is in August.

Allergan said the date was extended "to provide time for a full review" of the submission...