Bazedoxifene/conjugated estrogens regulatory update

Ligand and Pfizer said FDA accepted for review an NDA for bazedoxifene/conjugated estrogens (BZA/CE) to treat non-hysterectomized women with moderate to severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as to prevent postmenopausal osteoporosis. The PDUFA date is Oct. 3, 2013. In July, Pfizer said EMA accepted for review an MAA for BZA/CE to treat symptoms associated with menopause and osteoporosis. ...