Requests that the FDA take a form of the indications and usage section of the Full Prescribing Label for Premarin tablets for dosages 0.30 mg and 0.45 mg be re-written | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-6074

Requests that the FDA take a form of the indications and usage section of the Full Prescribing Label for Premarin tablets for dosages 0.30 mg and 0.45 mg be re-written

Documents

Comments

Description

Open

Key Dates

Comment Period OpensNov 13, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response	May 8, 2026	--

Keywords

CDER

Citizen Petition

Diamond Research Foundation

Requests that the FDA take a form of the

indications and usage section of the

Full Prescribing Label for Premarin tablets for

dosages 0.30 mg and 0.45 mg be re-written

as follows: From: INDICATIONS AND USAGE

Data from Regulations.gov