Lupin Limited and its alliance partner Natco Pharma Limited have received approval from the United States Food and Drug Administration for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials. The approval covers Natco's Abbreviated New Drug Application for the product.
Eribulin Mesylate Injection is the bioequivalent to the reference listed drug Halaven Injection of Eisai Inc. The drug treats adults with metastatic breast cancer who have received at least two prior chemotherapeutic regimens for metastatic disease. It is also indicated for unresectable or metastatic liposarcoma in patients who have received a prior anthracycline-containing regimen.
Halaven had estimated annual sales of USD 43.7 million in the United States, based on IQVIA MAT data for April 2026.
Lupin Limited is headquartered in Mumbai and distributes products across more than 100 markets. Lupin's portfolio includes branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin operates 15 manufacturing sites and 7 research centers globally with over 24,000 employees. Lupin's therapy areas include respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.
Lupin has a presence in the United States generics market across multiple therapy segments. The approval of Eribulin Mesylate Injection expands Lupin's oncology product offerings in the US market.
The announcement was made through a regulatory filing with the National Stock Exchange of India and BSE Limited.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.