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The 27 New Drugs Approved by the FDA in 2013

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Duavee for hot flashes from menopause
Duavee.jpg

Duavee package information

Pfizer

Duavee was approved for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause and for the prevention of postmenopausal osteoporosis on October 3, 2013.

Duavee is the first therapy to pair conjugated estrogens with an estrogen agonist/antagonist. Duavee is made with bazedoxifene rather than a progestin to help protect the uterine lining against hyperplasia that may result from estrogen-only treatment. It is only intended for women that still have a uterus.

During clinical trials the most common side effects reported were muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, and neck pain. As with other products containing estrogen, Duavee carries a boxed warning outlining the risks of long-term estrogen use. 

Generic name: conjugated estrogens/bazedoxifene

FDA announcement: FDA approves Duavee to treat hot flashes and prevent osteoporosis

Product website: duavee.com

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