Overview
A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the thymidylate synthetase conversion of deoxyuridylic acid to thymidylic acid.
Indication
For the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid.
Associated Conditions
- Actinic Keratosis (AK)
- Breast Cancer
- Colon Cancer
- Gastric Cancer
- Pancreatic Cancer
- Rectal Cancer
- Superficial Basal Cell Carcinoma
- Verruca (Warts)
- Hyperkeratotic actinic keratosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/17 | Not Applicable | Not yet recruiting | |||
2025/07/17 | Not Applicable | Not yet recruiting | |||
2025/07/09 | Not Applicable | Recruiting | Zhejiang Doer Biologics Co., Ltd. | ||
2025/06/29 | Not Applicable | Not yet recruiting | |||
2025/06/27 | Not Applicable | Not yet recruiting | |||
2025/06/19 | Phase 2 | Not yet recruiting | GERCOR - Multidisciplinary Oncology Cooperative Group | ||
2025/06/17 | Phase 1 | Not yet recruiting | |||
2025/06/12 | Phase 2 | Not yet recruiting | |||
2025/06/11 | Phase 4 | Not yet recruiting | Beijing GoBroad Hospital | ||
2025/05/31 | Phase 3 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Encube Ethicals Private Limited | 21922-041 | TOPICAL | 50 mg in 1 mL | 11/7/2023 | |
| BluePoint Laboratories | 68001-524 | INTRAVENOUS | 50 mg in 1 mL | 10/27/2023 | |
| Taro Pharmaceutical Industries Ltd. | 52549-4118 | TOPICAL | 50 mg in 1 g | 8/18/2010 | |
| NuCare Pharmaceuticals,Inc. | 68071-3489 | TOPICAL | 50 mg in 1 g | 8/24/2023 | |
| Mayne Pharma Inc. | 51862-362 | TOPICAL | 50 mg in 1 g | 11/4/2021 | |
| Bausch Health US, LLC | 0187-5200 | TOPICAL | 5 mg in 1 g | 5/17/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-2961 | TOPICAL | 50 mg in 1 g | 3/20/2023 | |
| Accord Healthcare, Inc. | 16729-276 | INTRAVENOUS | 50 mg in 1 mL | 2/23/2017 | |
| Mylan Pharmaceuticals Inc. | 0378-8078 | TOPICAL | 5 mg in 1 g | 1/15/2019 | |
| Fresenius Kabi USA, LLC | 63323-117 | INTRAVENOUS | 50 mg in 1 mL | 4/24/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FLUOROURACIL INJECTION 50 mg/ml | SIN09904P | INJECTION | 50 mg/ml | 7/23/1998 | |
| DBL Fluorouracil Injection BP 50mg/mL | SIN05050P | INJECTION | 50 MG/ML | 9/6/1990 | |
| VERRUMAL SOLUTION | SIN04266P | SOLUTION | 0.5 g/100 g | 4/30/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Fluorouracil Tablets | 国药准字H34023446 | 化学药品 | 片剂 | 5/11/2021 | |
| Fluorouracil Tablets | 国药准字H44020127 | 化学药品 | 片剂 | 4/16/2020 | |
| Fluorouracil Tablets | 国药准字H42021566 | 化学药品 | 片剂 | 6/10/2020 | |
| Fluorouracil Tablets | 国药准字H22021083 | 化学药品 | 片剂 | 1/9/2020 | |
| Fluorouracil Tablets | 国药准字H14020911 | 化学药品 | 片剂 | 6/22/2020 | |
| Fluorouracil for Injection | 国药准字H20050330 | 化学药品 | 注射剂 | 12/14/2022 | |
| Fluorouracil for Injection | 国药准字H20050981 | 化学药品 | 注射剂 | 7/30/2024 | |
| Fluorouracil for Injection | 国药准字H20050331 | 化学药品 | 注射剂 | 12/14/2022 | |
| Fluorouracil for Injection | 国药准字H20051626 | 化学药品 | 注射剂 | 4/8/2020 | |
| Fluorouracil for Injection | 国药准字H20051113 | 化学药品 | 注射剂 | 3/9/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FLUOROURACIL EBEWE fluorouracil 1000mg/ 20mL solution for injection vial | 98545 | Medicine | A | 3/15/2006 | |
| Hospira Fluorouracil Injection BP 1 g/20 mL vial | 119432 | Medicine | A | 5/24/2005 | |
| FLUOROURACIL INTAS fluorouracil 5000 mg/100 mL injection vial | 285806 | Medicine | A | 6/8/2018 | |
| ACTIKERALL fluorouracil and salicylic acid 0.5% / 10% (w/w) topical solution, bottle | 287446 | Medicine | A | 8/15/2019 | |
| FLUOROURACIL EBEWE fluorouracil 5000 mg/100 mL solution for injection vial | 166741 | Medicine | A | 3/24/2011 | |
| Hospira Fluorouracil Injection BP 2.5 g/50 mL Vial | 380183 | Medicine | A | 12/3/2021 | |
| FLUOROURACIL INTAS fluorouracil 2500 mg/50 mL injection vial | 285804 | Medicine | A | 6/8/2018 | |
| FLUOROURACIL AGILA fluorouracil 5 g/100 mL solution for injection vial | 233665 | Medicine | A | 1/14/2022 | |
| Hospira Fluorouracil Injection USP 5g/100mL vial | 63029 | Medicine | A | 1/19/1998 | |
| FLUOROCREM fluorouracil 5%w/w cream tube | 384712 | Medicine | A | 5/23/2023 |
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