Natco Pharma, Lupin Get US FDA Nod for Eribulin Mesylate Injection

Natco Pharma Limited and its alliance partner Lupin Limited have received approval from the United States Food and Drug Administration (U.S. FDA) for their Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection. This injection is a bioequivalent to Eisai, Inc.'s Halaven® Injection. Eribulin Mesylate Injection is indicated for treating metastatic breast cancer and unresectable or metastatic liposarcoma. The reference drug, Halaven®, had estimated annual sales of USD 43.7 million in the U.S. as of April 2026. This approval marks a significant step for both companies in the oncology market.