Allergan Uterine Fibroids Therapy Hits Regulatory Setback

Allergan Uterine Fibroids Therapy Hits Regulatory Setback

Source: 
BioCentury
snippet: 

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.