EFUDEX

FDA-2020-P-2213 · 6 docket documents

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-2019-P-2074 · 4 docket documents

Encube Ethicals Private Limited filed this citizen petition requesting that the FDA designate Fluorouracil Topical Solution, 5% manufactured by Taro Pharmaceutical Industries Ltd. and approved under ANDA A076526 as the Reference Standard for the product, because the current Reference Standard EFUDEX

FDA-2018-P-1453 · 19 docket documents

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 · 19 docket documents

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 · 4 docket documents

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 · 4 docket documents

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