Duavee

NDA 22247, held by Wyeth Pharms. Bazedoxifene Acetate; Estrogens, Conjugated.

As of Nov 13, 2026, NDA 22247 (Duavee), held by Wyeth Pharms, was first approved by FDA on Oct 3, 2013, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 3, 2013
Review: Standard
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (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
Prevention of postmenopausal osteoporosis Limitation of Use: DUAVEE should be used for the shortest duration consistent with treatment goals and risks for the individual woman 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause 1.2 Prevention of Postmenopausal Osteoporosis 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Oct 3, 2013	Original applicationNew molecular entity, new combination · Standard review	Approved	Label Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
DuaveeEQ 20MG BASE;0.45MG · tablet;oral	Bazedoxifene Acetate; Estrogens, Conjugated	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Mar 4, 2024	Supplement 10Labeling · Standard review	Approved	Label Letter
Dec 6, 2022	Supplement 7Labeling · Standard review	Approved	Letter Label
Dec 18, 2019	Supplement 6Labeling · Standard review	Approved	Letter Label
Nov 1, 2017	Supplement 4Labeling · Standard review	Approved	Label
Sep 25, 2015	Supplement 2Labeling · Standard review	Approved	Label Letter
Jul 23, 2015	Supplement 1Labeling · Standard review	Approved	Label Letter
Oct 3, 2013	Original applicationNew molecular entity, new combination · Standard review	Approved	Label Review Label Letter

Identifiers

Application: NDA 22247
Drugs@FDA: Overview at FDA
Company: Wyeth Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters