FDA accepts NDA filings from Pfizer/Ligand and Actelion; Bayer submits Alpharadin
The US Food and Drug Administration accepted for review a New Drug Application from pharma behemoth Pfizer (NYSE: PFE) and partner Ligand Pharmaceuticals (Nasdaq: LGND) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis. The FDA Prescription Drug User Fee Act (PDUFA) date is October 3, 2013.
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