Pfizer files Aprela at FDA for Menopausal Symptoms and Prevention of Osteoporosis

Pfizer Inc. and Ligand Pharmaceuticals Incorporated have announced that the FDA accepted for review a New Drug Application for Aprela ( bazedoxifene/conjugated estrogens ), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms and vulvar and vaginal atrophy associated with Menopause, as well as the prevention of postmenopausal Osteoporosis. The FDA Prescription Drug User Fee Act (PDUFA) date is October 3, 2013.