Lupin and its alliance partner Natco Pharma have announced that the US Food and Drug Administration (FDA) has approved Natco’s Abbreviated New Drug Application (ANDA) for breast cancer drug Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials.
The approved product is a generic version of Eisai’s Halaven (eribulin mesylate) Injection and is indicated for the treatment of adults with metastatic breast cancer (mBC) who have previously received at least two chemotherapy regimens for metastatic disease. It is also approved for patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
According to IQVIA MAT April 2026 data, the reference product Halaven recorded estimated annual sales of USD 43.7 million in the US market.
Halaven is an FDA-approved chemotherapy medicine originally developed from a natural substance found in a sea sponge. It is used in adults with breast cancer that has spread to other parts of the body after prior anticancer treatments.
In a clinical study involving more than 750 women with metastatic breast cancer, patients treated with Halaven lived an average of 25 per cent longer compared to those receiving other commonly used chemotherapies or hormone therapies.
Based on laboratory research, eribulin works by interfering with cancer cell division, leading to cancer cell death and potentially reducing the ability of remaining tumour cells to spread.
