Lupin and Natco Receive FDA Approval for Eribulin Mesylate Injection
Global pharmaceutical major Lupin Limited, in partnership with alliance partner Natco Pharma Limited, announced that they have received approval from the United States Food and Drug Administration (U.S. FDA). The approval pertains to Natco's Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials.The approved product is the bioequivalent of Eisai, Inc.'s reference listed drug (RLD), Halaven® Injection. This medication is designed for treating specific conditions in advanced cancer patients.
Eribulin Mesylate Injection has been indicated for the treatment of adults suffering from metastatic breast cancer. These patients must have previously received at least two chemotherapeutic regimens for their metastatic disease. Furthermore, it is also intended for unresectable or metastatic liposarcoma cases where the patient has undergone a prior anthracycline-containing regimen.
The market potential of Eribulin Mesylate Injection is significant. The reference listed drug (RLD Halaven®) had estimated annual sales of USD 43.7 million in the U.S., according to estimates from IQVIA MAT April 2026.
Lupin Limited, headquartered in Mumbai, India, operates as a global pharmaceutical leader with products distributed across more than 100 markets. The company specializes in various pharmaceutical formulations, including generic and complex generics, biotechnology products, and active pharmaceutical ingredients, maintaining a presence across multiple therapy areas globally.
LUPIN Stock Price Movement
As of 11:06 AM, shares of Lupin Limited are slipping by 0.49% in live trading, currently at ₹2238.7. The pharmaceutical stocks sees heavy movement as 121,008 shares have been traded during the active session.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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