FERAHEME

FDA-2025-P-6222 · 11 docket documents

Law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA require submission of a Prior Approval Supplement with bioequivalence testing when sponsors of carbohydrate-iron complex products such as ferric carboxymaltose, ferric derisomaltose, ferumoxytol, iron dextran

FDA-2013-P-1294 · 5 docket documents

On September 30, 2013, Luitpold Pharmaceuticals Inc., through counsel at Sheppard Mullin Richter & Hampton LLP, filed a citizen petition requesting that the FDA approve any New Drug Application or supplement for injectable iron products treating iron deficiency anemia outside chronic kidney disease

FDA-2013-P-0885 · 3 docket documents

AMAG Pharmaceuticals, Inc., sponsor of Feraheme (ferumoxytol) injection approved under NDA 22-180, filed this citizen petition under 21 USC 355 and 21 CFR 10.30 requesting that FDA refrain from approving any ANDA for a generic version of Feraheme until post-market contract studies on the generic sod

FDA-2008-P-0524 · 5 docket documents

Luitpold Pharmaceuticals, Inc. filed this citizen petition on September 23, 2008, requesting that the FDA require any new drug application (NDA) for ferumoxytol for iron deficiency anemia to contain the same rigorous clinical trial data and safety labeling as other intravenous iron dextran products,