OZEMPIC

FDA-2025-P-7376 · 8 docket documents

The WhiteOak Group, LLC, on behalf of Hybio Pharmaceutical Co., Ltd., filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that FDA declare Semaglutide Injection in five strengths (1 mg/1.5 mL, 2 mg/1.5 mL, 4 mg/3 mL, 6.8

FDA-2025-P-3849 · 5 docket documents

Hyman, Phelps & McNamara, P.C. filed this petition requesting that the FDA determine whether OZEMPIC (semaglutide) Injection, 2 mg/1.5 mL (1.34 mg/mL), approved under NDA 209637 and held by Novo Nordisk Inc., was withdrawn for safety or effectiveness reasons pursuant to sections 505(j) and 505(w) of

FDA-2025-P-3481 · 3 docket documents

Foley & Lardner LLP, on behalf of Adventapharma DWC-LLC, filed this citizen petition under 21 CFR 10.30 requesting that the FDA refrain from approving any ANDA for generic semaglutide injection (Ozempic, NDA N209637) unless the generic product includes a pen injector functionally equivalent to the r

FDA-2025-P-3368 · 3 docket documents

Foley & Lardner LLP on behalf of Adventapharma DWC-LLC filed this citizen petition under 21 CFR 10.30 requesting that the FDA refrain from approving any ANDA for generic semaglutide injection (Ozempic, NDA N209637) unless the generic product includes a pen injector functionally equivalent to the ref

FDA-2025-P-3239 · 4 docket documents

Wiley Rein LLP filed this citizen petition on behalf of an unnamed client on August 19, 2025, requesting that the FDA Commissioner take regulatory action to address public health risks associated with large-scale production and distribution of compounded semaglutide preparations. The petitioner requ

FDA-2025-P-3103 · 3 docket documents

Foley & Lardner, LLP filed this citizen petition on behalf of an unnamed client requesting that the FDA refrain from approving Abbreviated New Drug Applications (ANDAs) for generic semaglutide injection referencing the reference listed drug Ozempic (N209637) unless the generic product includes a pen

FDA-2024-P-5378 · 9 docket documents

Novo Nordisk Inc. filed a citizen petition requesting that the FDA add semaglutide products to the demonstrable difficulties for compounding lists under Federal Food, Drug, and Cosmetic Act sections 503A and 503B, citing formulation complexities, delivery mechanism differences, and public health ris

FDA-2024-P-4937 · 4 docket documents

Covington & Burling LLP, on behalf of Novo Nordisk Inc., filed this citizen petition requesting that the FDA exclude semaglutide from the 503B Bulks List, rescind the 503B Interim Policy in its entirety, and exclude semaglutide from Category 1 of the 503B Interim Policy. The petition argues that sem

FDA-2024-P-1223 · 5 docket documents

Charles Ludlam filed this citizen petition requesting that the FDA require additional clinical trials and modify product labels for tirzepatide (Mounjaro/Zepbound) and semaglutide (Ozempic/Wegovy) to address lean muscle mass loss, ideal goal weight setting, and weight loss maintenance strategies, ci

FDA-2023-P-2507 · 30 docket documents

The Physicians Committee for Responsible Medicine filed this citizen petition requesting that the Food and Drug Administration Commissioner require manufacturers of glucagon-like peptide-1 receptor agonists, including semaglutide, to include labeling disclosing that low-fat plant-based diets have co

FDA-2017-P-6029 · 30 docket documents

Novo Nordisk Inc. filed a citizen petition requesting that FDA establish weight-based dosing guidance for semaglutide and similar GLP-1 receptor agonists to improve pediatric treatment efficacy and safety, along with potential updates to existing NDA labeling to reflect the proposed dosing recommend