Regulatory Disclosure and Product Approval
Lupin Limited and its alliance partner Natco Pharma Limited announced receipt of 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.
Product Details and Therapeutic Indications
The approved product is bioequivalent to the reference listed drug (RLD) Halaven® Injection of Eisai, Inc. Eribulin Mesylate Injection is indicated for:
- Treatment of adults with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease
- Treatment of adults with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen
Market Context
The reference listed drug Halaven® had estimated annual sales of USD 43.7 million in the U.S. market based on IQVIA MAT data through April 2026.
Company Background
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in pharmaceutical products including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin maintains 15 manufacturing sites and 7 research centers globally with over 24,000 professionals.
Legal Disclaimer
Halaven® is a registered trademark of Eisai R&D Management Co., Ltd.