DUAVEE

FDA-2026-P-1450

Beth Rosenshein of the Diamond Research Foundation requests that the FDA update Section 5.2 of the Full Prescribing Information for Duavee tablets (conjugated estrogens/bazedoxifene) to include information about the increased risk of venous thromboembolism when using the combination of the selective

FDA-2025-P-6074

Beth Rosenshein of the Diamond Research Foundation submitted this petition requesting that the FDA revise the INDICATIONS AND USAGE section of the prescribing label for Premarin tablets at 0.30 mg and 0.45 mg dosages to remove the indication for treatment of hypoestrogenism due to hypogonadism, cast

FDA-2016-P-3082

Pfizer Inc., through counsel at Ropes & Gray LLP, filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA recognize 5-year exclusivity under sections 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) for bazedoxifene, the new active moiety in DUAVEE (con

FDA-2014-P-0737

Pfizer Inc filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA recognize five-year exclusivity under sections 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) for bazedoxifene, the new active moiety in DUAVEE, a fixed-dose combination of conjugated