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Pfizer gets FDA approval for menopause pill

CHICAGO (AP) -- Pfizer said Thursday the Food and Drug Administration approved its new hormone pill, Duavee, to treat hot flashes and osteoporosis associated with menopause.

Regulators approved the drug for women who still have a uterus and are experiencing moderate to severe hot flashes. The drug is also approved to help prevent postmenopausal osteoporosis, which can cause bones to become brittle and crack.

The drug is a once-daily pill that combines the female hormone estrogen with the drug bazedoxifene. The drug represents an alternative to older menopause pills that combined estrogen with another hormone: progestin, which has been linked to increased risk of lung and breast cancer.

Like all hormone therapies, Pfizer says the new drug should be used for "the shortest duration" possible to relieve symptoms, due to the potential health risks. The New York-based drugmaker said it expects to launch the drug in the first quarter of 2014.

The drugs label states that Duavee should not be used by women with a history of blood clots or certain cancers, including cancer of the uterus and breast.

For decades, doctors believed hormone pills helped prevent heart problems and were good for bones and minds. That changed in 2002, when a big federal study was stopped because women taking estrogen-progestin pills had higher rates of cardiovascular disease and cancer.

Pfizer's approval comes the same week that researchers released the largest update yet to the landmark government 2002 study tracking women taking the hormone pills. The results published in the Journal of American Medical Association reaffirmed earlier recommendations: only use hormones to treat hot flashes and other menopause symptoms for short periods of time.

Ligand Pharmaceuticals Inc., a partner of Pfizer, is earning a milestone payment of $425,000 on the drug's approval. Shares of the Dan Diego company rose $3.13, or 7 percent, to close at $47.99.

Shares of Pfizer Inc. fell 24 cents Thursday to close at $28.77.