Natco Pharma (NATCO) and its alliance partner Lupin have received the approval from the United States Food and Drug Administration (USFDA) for NATCO’s Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2ml (0.5 mg/ml) Single-Dose Vials.
Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is the bioequivalent to the reference listed drug (RLD) Halaven Injection of Eisai, Inc. Eribulin Mesylate Injection is indicated for the treatment of adults with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease and unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
Eribulin Mesylate Injection (RLD Halaven) had estimated annual sales of $43.7 million in the U.S. (IQVIA MAT April 2026).
Natco Pharma is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of Finished Dosage Formulations (FDF) and Active Pharmaceutical Ingredients (APIs).
