FDA Accepts NDA for Investigational Menopause, Osteoporosis Drug

Pfizer and Ligand Pharmaceuticals announced that the FDA accepted for review a New Drug Application (NDA) for bazedoxifene/conjugated estrogens (BZA/CE), 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. BZA/CE pairs the selective estrogen receptor modulator (SERM) bazedoxifene with conjugated estrogens.

BZA/CE has been studied in a Phase 3 clinical development program (Selective estrogens, Menopause And Response to Therapy [SMART] trials), which included approximately 7,500 postmenopausal women.

For more information visit www.pfizer.com or www.ligand.com.