Duavee (combination) and Gilteritinib Fumarate

• Generic Name: bazedoxifene / conjugated estrogens
• Dosage Forms: n.a.
• Other Brand Names: Duavee

Bazedoxifene/conjugated estrogens in fixed combination: Prevention of osteoporosis in postmenopausal women with an intact uterus.

Not FDA-labeled for treatment of osteoporosis in postmenopausal women in the US. Bazedoxifene commercially available in other countries for this use.

Not recommended for prevention of osteoporosis in premenopausal women; safety and efficacy not established.

Bazedoxifene/conjugated estrogens in fixed combination: Management of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus.

• Generic Name: gilteritinib
• Dosage Forms: n.a.
• Other Brand Names: Xospata

For the treatment of relapsed or refractory AML harboring Flt-3 mutation (designated an orphan drug by FDA for this use).

FDA-approved companion diagnostic test (e.g., LeukoStrat CDx Flt-3 mutation assay) required to confirm presence of Flt-3 mutation prior to initiation of therapy.