Requests that the FDA add Pharmacokinetic Parameters for estradiol be added to Table 2 in Section 12.3 of the full prescribing information inser for all doses of Premarin. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4854

Requests that the FDA add Pharmacokinetic Parameters for estradiol be added to Table 2 in Section 12.3 of the full prescribing information inser for all doses of Premarin.

Documents

Comments

Key Dates

Comment Period OpensMay 5, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	National Library of Medicine estrone content	May 5, 2026	--

Keywords

CDER

Citizen Petition

Diamond Research Foundation

add Pharmacokinetic

Parameters for estradiol be added to

Table 2 in Section 12.3 of the full prescribing

information insert for all doses of Premarin

OPEN

Data from Regulations.gov