PREMARIN

FDA-2026-P-4854 · 5 docket documents

Beth Rosenshein of the Diamond Research Foundation requests that the FDA require Pfizer to add pharmacokinetic parameters for unconjugated and conjugated estradiol to Table 2 in Section 12.3 of the Full Prescribing Information for all doses of Premarin tablets (0.30 mg, 0.45 mg, 0.625 mg, 0.90 mg, a

FDA-2025-P-7111 · 7 docket documents

Beth Rosenshein of the Diamond Research Foundation submitted a citizen petition requesting that the FDA update the Indications and Usage section of the Full Prescribing Information for Premarin tablets to include information about equilin, a major component comprising 22-30% of the drug that may fun

FDA-2025-P-6074 · 5 docket documents

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-2018-P-3325 · 18 docket documents

Pfizer Inc. filed this citizen petition under 21 USC 355 and 21 CFR 10.30 regarding any abbreviated new drug application for a generic version of Premarin (conjugated estrogens), requesting that FDA develop new guidance for assessing sameness of conjugated estrogens products using a method capable o