On 03rd June, 2026 Lupin Limited (Lupin) announced that, Lupin and its alliance partner Natco Pharma Limited (Natco) got the 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.
Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is the bioequivalent to the reference listed drug (RLD) Halaven® Injection of Eisai, Inc. It is used for the treatment of adults with metastatic breast cancer, for thosewho have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease, and unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
According to the IQVIA data (MAT April 2026), Halaven®had estimated annual sales in the U.S. only of around $43.7 million.
Lupin Limited (Lupin), headquartered in Mumbai, India, is a pharmaceutical company with operations across more than 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Natco Pharma, based in Hyderabad, India, is known for its focus on niche pharmaceutical products and partnerships that enhance global reach.
This FDA approval unveils both companies’ commitment to advancing oncology therapies and improving patient outcomes through accessible, high-quality medicines.
Written by: Pramit Hazra
Graphics by: Pramit Hazra
