FDA approves Pfizer drug for hot flashes

Agency announces approval of Duavee, first estrogen-estrogen agonist and antagonist combination pill

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for hot flashes and the prevention of osteoporosis, the agency said.

The FDA announced the approval of Duavee (conjugated estrogens; bazedoxifene), made by Pfizer. The drug is for women who suffer from moderate to severe hot flashes associated with menopause, and is also designed to prevent osteoporosis after menopause.

The drug is the first approved by the agency that combines estrogen with an estrogen agonist or antagonist, in this case bazedoxifene, which is designed to reduce the risk of excessive growth of the lining of the uterus, also known as endometrial hyperplasia, which can occur from estrogen. The drug is only meant for postmenopausal women who still have a uterus.

 

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