conjugated estrogens/bazedoxifene
Drug Details
- Generic Name
- conjugated estrogens/bazedoxifene
- Brand Names
- Duavee
- Application Number
- NDA022247
- Sponsor
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- NDC Codes
- 2
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- BAZEDOXIFENE ACETATE, ESTROGENS, CONJUGATED
Indications and Usage
1 INDICATIONS AND USAGE DUAVEE is indicated in women with a uterus for: DUAVEE is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus: • Treatment of moderate to severe vasomotor symptoms associated with menopause ( 1.1 ) • Prevention of postmenopausal osteoporosis ( 1.2 ) Limitation of Use : DUAVEE should be used for the shortest duration consistent with treatment goals and risks for the individual woman ( 1.3 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause 1.2 Prevention of Postmenopausal Osteoporosis 1.3 Important Limitations of Use • Use DUAVEE for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. • When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.