FDA Approves Pfizer’s Duavee To Treat Hot Flashes, Prevent Osteoporosis

The Food and Drug Administration Oct. 3 said it has approved Duavee (conjugated estrogens/bazedoxifene) for women who suffer from moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and to prevent osteoporosis after menopause.

Duavee is the first drug approved by the FDA that combines estrogen with an estrogen agonist/antagonist (bazedoxifene), according to the agency. It is marketed by Pfizer Inc.

The bazedoxifene component reduces the risk of endometrial hyperplasia (excessive growth of the lining of the uterus) that can occur with the estrogen component of Duavee, the agency said. Duavee is intended only for postmenopausal women who still have a ...