Lupin Limited (Lupin) and its alliance partner Natco Pharma Limited (Natco) announced on June 03, 2026, that they have received approval from the United States Food and Drug Administration (U.S. FDA) for Natco's Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials. This Eribulin Mesylate Injection is bioequivalent to the reference listed drug (RLD) Halaven® Injection, developed by Eisai, Inc. The injection is indicated for the treatment of adults with metastatic breast cancer who have previously undergone at least two chemotherapeutic regimens for metastatic disease. It is also indicated for unresectable or metastatic liposarcoma after prior anthracycline-containing therapy. Eribulin Mesylate Injection (RLD Halaven®) had estimated annual sales of USD 43.7 million (approximately ₹363 crore) in the U.S. as of April 2026.
