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Published on 6/26/2006 in the Prospect News Biotech Daily.

Wyeth Pharmaceuticals submits NDAs for menopausal, postmenopausal symptoms

By Lisa Kerner

Charlotte, N.C., June 26 - Wyeth Pharmaceuticals said it has submitted two New Drug Applications to the Food and Drug Administration.

One is for the approval of bazedoxifene, a Selective Estrogen Receptor Modulator investigated for the prevention of postmenopausal osteoporosis.

The second application is for desvenlafaxine succinate, a non-hormonal agent for the treatment of moderate to severe vasomotor symptoms, such as hot flashes and night sweats, associated with menopause.

"If approved, both bazedoxifene and desvenlafaxine succinate will give physicians additional options to help meet the individualized needs of their menopausal patients," senior vice president Joseph Camardo said in a company news release.

There are approximately 40 million U.S. women of menopausal age, according to the North American Menopause Society. As many as 93% of women going through menopause experience vasomotor symptoms.

Located in Madison, N.J., Wyeth Pharmaceuticals, a division of Wyeth, specializes in products for women's health care, cardiovascular disease, the central nervous system, inflammation, transplantation, hemophilia and oncology as well as vaccines and nutritional products.


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