MUMBAI, India and NAPLES, Fla. — Lupin Ltd. and alliance partner Natco Pharma Ltd. have received approval from the U.S. Food and Drug Administration for Natco’s abbreviated new drug application for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials.
The product is the bioequivalent of Eisai’s Halaven Injection and is indicated for the treatment of adults with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease. It is also approved for patients with unresectable or metastatic liposarcoma who have previously received an anthracycline-containing regimen.
According to IQVIA data for the 12 months ended April 2026, U.S. sales of Halaven totaled approximately $43.7 million.
The approval expands the portfolio of oncology products available through the Lupin-Natco partnership in the U.S. market.
Mumbai-based Lupin markets pharmaceutical products in more than 100 countries and has a presence across multiple therapeutic categories, including respiratory, cardiovascular, diabetes, anti-infective, gastrointestinal, central nervous system and women’s health. The company operates 15 manufacturing facilities and seven research centers worldwide.
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