Wyeth submits 2 NDAs for menopause drugs

US drug major Wyeth Pharmaceuticals has submitted two New Drug Applications to the Food and Drug Administration. It is seeking marketing authorization for bazedoxifene, a selective estrogen receptor modulator investigated for the prevention of postmenopausal osteoporosis, as well as for desvenlafaxine succinate, a non-hormonal agent studied for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.

Joseph Camardo, senior vice president of Wyeth's global medical affairs, said that "if approved, both bazedoxifene and desvenlafaxine succinate will give physicians additional options to help meet the individualized needs of their menopausal patients. The simultaneous submission of these two separate NDAs emphasizes Wyeth's position as a leader and innovator in women's health."