Natco Pharma Limited (NATCO), in alliance with Lupin Limited, announced on June 3rd, 2026, the 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/2ml (0.5 mg/ml) Single-Dose Vials. This approved Eribulin Mesylate Injection is bioequivalent to the reference listed drug, Halaven® Injection, manufactured by Eisai, Inc. The drug is indicated for the treatment of adults with metastatic breast cancer who have undergone at least two prior chemotherapy regimens for metastatic disease, and for unresectable or metastatic liposarcoma patients who have previously received an anthracycline-containing regimen. Eribulin Mesylate Injection (RLD Halaven®) had reported estimated annual sales of USD 43.7 million in the U.S. as of April 2026 (IQVIA MAT April 2026). NATCO Pharma Limited, headquartered in Hyderabad, India, is a research and development-driven pharmaceutical company specializing in generic and specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products, with a focus on limited competition molecules in the U.S. market.
