Wyeth Pharmaceuticals, a division of Wyeth, announced that the U.S. Food and Drug Administration (FDA) has approved a new low dose strength of Prempro (conjugated estrogens [CE]/ medroxyprogesterone acetate [MPA] tablets), containing 0.3 mg CE and 1.5 mg MPA. Prempro 0.3 mg/1.5 mg is approved for the treatment of moderate to severe symptoms associated with menopause, such as hot flashes, night sweats, and vaginal dryness; and for the prevention of postmenopausal osteoporosis. The Company also announced that FDA has expanded the approved uses for Prempro 0.45 mg/1.5 mg to include the prevention of postmenopausal osteoporosis.

Together, these approvals represent an important first for Prempro. Now symptomatic menopausal women who require combination estrogen plus progestin therapy will have two low dose options.

Women should take the lowest effective dose of postmenopausal hormone therapy for the shortest duration consistent with treatment goals and risks for the individual woman. The FDA, other health experts, and Wyeth recommend that when used solely for the prevention of postmenopausal osteoporosis, hormone therapy should be considered only for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.

Wyeth expects to have Prempro 0.45 mg/1.5 mg available in early summer 2003, and Prempro 0.3 mg/1.5 mg available in late 2003.

"These approvals mean that women and clinicians will have two low dose options to better individualize effective treatment for menopausal symptom relief and concomitant bone protection," says Victoria Kusiak, Vice President Global Medical Affairs, and North American Medical Director, Wyeth Pharmaceuticals.

Postmenopausal estrogen therapy, which was first introduced more than 60 years ago, remains an important therapeutic option for menopausal women. In the U.S. alone, over 4,000 women a day enter menopause. For many women, menopausal symptoms are a very important health issue. Symptoms can disrupt a woman's daily activities at home or work, interrupt her sleep, contribute to fatigue, and interfere with intimacy. Postmenopausal estrogen/hormone therapy is the only FDA-approved treatment indicated for the relief of menopausal symptoms and the concomitant prevention of postmenopausal osteoporosis.