Manages gastrointestinal adenocarcinoma metastatic. ANDA 75837, held by Fresenius Kabi USA. Floxuridine.
As of Nov 15, 2026, ANDA 75837 (Floxuridine), held by Fresenius Kabi USA, was first approved by FDA on Feb 22, 2001, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: Floxuridine for Injection, USP is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Floxuridine500MG/VIAL · injectable;injection | Floxuridine | Rx |
| Dec 5, 2002 | Supplement 4Manufacturing | Approved | None posted |
| Nov 26, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Nov 26, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Nov 26, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Feb 22, 2001 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
