ANDA 219054, held by Xgen Pharms. Eribulin Mesylate.
As of Nov 15, 2026, ANDA 219054 (Eribulin Mesylate), held by Xgen Pharms, was first approved by FDA on Mar 16, 2026, with 0 approved supplements and 0 published complete response letters.
Eribulin mesylate injection is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. 1.1 Metastatic Breast Cancer Eribulin mesylate injection is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 16, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Eribulin Mesylate1MG/2ML (0.5MG/ML) · solution;intravenous | Eribulin Mesylate | Rx |
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
