Manages gastrointestinal adenocarcinoma metastatic. ANDA 75387, held by Hikma. Floxuridine.
As of Nov 15, 2026, ANDA 75387 (Floxuridine), held by Hikma, was first approved by FDA on Apr 6, 2000, with 1 approved supplement 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 |
|---|---|---|---|
| Apr 6, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Floxuridine500MG/VIAL · injectable;injection | Floxuridine | Rx |
| Jul 1, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Apr 6, 2000 | 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
