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As of Nov 15, 2026, ANDA 217250 (Eribulin Mesylate), held by Baxter Hlthcare Corp, was first approved by FDA on Oct 1, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Oct 1, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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.
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
