FLUOROURACIL

FDA-2020-P-2213

Kenneth E. Surprenant filed this citizen petition requesting that the FDA revise the package inserts for Fluorouracil and Xeloda (Capecitabine) to recommend pre-treatment testing for dihydropyrimidine dehydrogenase (DPD) deficiency, shift responsibility for identifying DPD deficiency from patients t

FDA-2020-P-2213

Kenneth E. Surprenant filed a petition requesting that the FDA revise the drug labels for Fluorouracil and Xeloda (Capecitabine) to recommend pre-treatment testing for Dihydropyrimidine Dehydrogenase (DPD) deficiency, shift responsibility for identifying DPD deficiency from patients to prescribing p

FDA-2018-P-1453

Spear Pharmaceuticals, Inc. filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA reaffirm its requirement that new abbreviated new drug applications seeking approval for generic fluorouracil cream 5% referencing the Efudex brand product mu

FDA-2018-P-1068

Spear Pharmaceuticals, Inc. filed this citizen petition opposing FDA consideration of alternative in vitro bioequivalence pathways for generic fluorouracil cream 5% (Efudex) ANDA approvals. Spear requests that the FDA continue requiring comparative clinical trials for generic Efudex products rather

FDA-2014-P-0405

Ken Surprenant filed this citizen petition requesting that the FDA revise the package insert for Fluorouracil to add dihydropyrimidine dehydrogenase deficiency as a contraindication, strengthen warnings about severe toxicity and fatalities associated with DPD deficiency, and add precautions recommen

FDA-2008-P-0218

Ebewe Parenta Pharmaceuticals, Inc. filed this suitability petition pursuant to 21 CFR §10.20 and §10.30, requesting that the FDA determine whether a 1 gm/20 mL (50 mg/mL) presentation of Fluorouracil Injection, USP can be added to its existing ANDA 40-772, which currently contains only the 500 mg/1