Lupin and Natco Receive U.S. FDA Approval for Eribulin Mesylate Injection
Lupin and Natco received U.S. FDA approval for Eribulin Mesylate Injection. The drug is bioequivalent to Halaven® Injection and is used for metastatic breast cancer and liposarcoma. The RLD had estimated annual sales of USD 43.7 million in the U.S.
The approval of a product with estimated annual sales of USD 43.7 million has a moderate financial impact on Lupin.
The U.S. FDA approval of Eribulin Mesylate Injection is a positive development for Lupin and Natco, opening up a significant market.
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.
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