PREMARIN

FDA-2026-P-8330 · 4 docket documents

The Diamond Research Foundation filed a citizen petition requesting that the FDA take action regarding diamond-based products and their regulatory status. The petition seeks clarification on whether certain diamond-containing formulations should be classified as drugs, devices, or dietary supplement

FDA-2026-P-7042 · 3 docket documents

Evan H. Couture filed this petition under 21 CFR 10.30 requesting that the FDA and DEA enforce the Prescription Drug Marketing Act with equal stringency against institutional collections as against individual citizens, investigate private holdings of restricted pharmaceutical samples, amend the PDMA

FDA-2026-P-6279 · 2 docket documents

Evan H. Couture filed this citizen petition requesting that the FDA legalize the public sale of refrigerated and pasteurized equine urine as a dietary supplement, approve home-collection and pasteurization kits for individual use, and establish regulatory parity with approved conjugated equine estro

FDA-2026-P-4854 · 5 docket documents

Beth Rosenshein of Diamond Research Foundation submitted this citizen petition requesting that the FDA direct 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,

FDA-2026-P-2971 · 7 docket documents

Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Conjugated Estrogen Tablets, 0.15 mg suitable for submission as an ANDA based on the reference listed drug PREMARIN Tablets by Wyeth Pharmaceuticals LLC (NDA #

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