FLUOROURACIL | N012209 | SPECTRUM PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kenneth E. Surprenant 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 | Other | 2020-11-19 | Partially Denied | Kenneth E. Surprenant |
Citizen Petition from Spear Pharmaceuticals, Inc 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 | 505(q) | 2018-04-10 | Denied | Spear Pharmaceuticals, Inc |
Citizen Petition from Spear Pharmaceuticals, Inc 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that the FDA continue requiring comparative clinical trials for generic Efudex products rather | Other | 2018-03-12 | Withdrawn | Spear Pharmaceuticals, Inc |
Citizen Petition From Ken Surprenant 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 | Other | 2014-04-08 | Partially Denied | Ken Surprenant |
Ebewe Parenta Pharmaceuticals, Inc. - Citizen Petition 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USP can be added to its existing ANDA 40-772, which currently contains only the 500 mg/1 | Other | 2008-12-02 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.