BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED | N022247 | WYETH PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Diamond Research Foundation 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 | Other | 2026-02-09 | Open | Diamond Research Foundation |
Citizen Petition from Ropes & Gray LLP (Pfizer Inc.) 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 | Other | 2016-10-04 | Granted | Ropes & Gray LLP (Pfizer Inc.) |
Citizen Petition from Pfizer Inc (Ropes and Gray LLP) 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 | Other | 2014-07-09 | Denied | Pfizer Inc (Ropes and Gray LLP) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7683051 | Mar 10, 2027 | — | Yes | Yes | — |