ARTICLE | Company News
Allergan uterine fibroids therapy hits regulatory setback
August 21, 2018 10:44 PM UTC
Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited safety concerns from ex-U.S. postmarketing reports.
Gedeon Richter plc (Budapest:RICHTER) markets ulipristal as Esmya in Europe for the same indication. Allergan, which has rights to the drug in the U.S. and Canada under a 2010 deal, markets ulipristal in Canada as Fibristal. The compound is a selective progesterone receptor modulator (SPRM)...