FDA accepts NDA for ulipristal acetate, a drug for the treatment of abnormal uterine bleeding in women with uterine fibroids.- Allergan.
Allergan plc announced that the FDA has accepted the New Drug Application (NDA) for ulipristal acetate, an investigational drug for the treatment of abnormal uterine bleeding in women with uterine fibroids. Allergan expects the ulipristal acetate Prescription Drug User Fee Act (PDUFA) action date to occur in the first half of 2018.
Comment: Ulipristal acetate, known as Esyma in the EU was approved to treat Uterine Fibroids in February 2013.
Comment:Forthcoming competition from AbbVie and Neurocrine Biosciences� phase III elagolix is negatively influencing expectations for Esmya; First Order Analytics estimated a $286 million peak sales consensus which falls well below the $500 million to $1 billion range Allergan itself claimed.
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